Abstract
Purpose
To evaluate 12-month visual and clinical outcomes after implantation of a monofocal aspheric hydrophobic acrylic intraocular lens (IOL) delivered with a preloaded system.
Methods
This investigator-initiated, prospective, single-center, uncontrolled feasibility study enrolled 30 patients undergoing unilateral or bilateral cataract surgery with implantation of the OPTIFLEX GENESIS COMFORT NY IOL. Twenty patients contributed 22 operative eyes to the per-treatment evaluable analysis at 12 months. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and intraocular pressure (IOP) were assessed postoperatively. Posterior capsule opacification (PCO), clinically detectable IOL tilt, decentration, discoloration, and higher-order aberrations were evaluated during follow-up.
Results
Mean preoperative UDVA and CDVA were 0.64 ± 0.33 and 0.30 ± 0.23 logMAR, respectively. Mean UDVA improved to 0.12 ± 0.16 logMAR at 3 months and 0.19 ± 0.16 logMAR at 12 months. Mean CDVA improved to −0.01 ± 0.10 logMAR at 3 months and 0.01 ± 0.09 logMAR at 12 months. IOP remained stable, and no statistically significant change in spherical equivalent refraction was observed, although a numerical hyperopic trend was noted. At 12 months, PCO was absent in 15 eyes and minimal in 7 eyes. No clinically detectable IOL tilt, decentration, or discoloration was recorded. Contrast sensitivity was generally within or close to age-matched reference ranges.
Conclusion
In this uncontrolled prospective feasibility cohort, implantation of the investigated monofocal aspheric hydrophobic acrylic IOL was associated with improved distance visual acuity and stable IOP through 12 months. The findings provide preliminary device-specific clinical data and should be confirmed in larger controlled studies with longer follow-up.
Keywords: intraocular lens, hydrophobic, aspheric, preloaded delivery system
Introduction
As the population continues to age, the demand for cataract surgeries accompanied by the implantation of artificial lenses has grown significantly. These procedures are essential to preserving vision and enabling individuals to manage daily tasks independently.1 Consequently, continuous technological developments in intraocular lens design, biomaterials, and delivery systems remain clinically relevant.
Today, a wide range of different IOLs is available, differing in material, optical characteristics, and handling. The key to success lies in customizing the lens to meet each patient’s unique needs, expectations, and comorbidities. Among these, monofocal lenses are the most commonly implanted, known for delivering excellent visual acuity at a fixed distance while maintaining high visual quality and contrast sensitivity.2,3
In addition to standard distance visual acuity, postoperative optical quality is influenced by IOL design and material properties. Aspheric monofocal IOLs are designed to reduce positive spherical aberration and may thereby support improved optical quality and contrast sensitivity, particularly under mesopic conditions or in situations with glare.4–7 These optical characteristics are clinically relevant because postoperative visual quality depends not only on visual acuity, but also on contrast sensitivity and higher-order aberrations.
The material of the IOL also plays a central role. Biomaterials such as acrylic and silicone are commonly used and significantly influence long-term postoperative outcomes, particularly the development of posterior capsule opacification (PCO). The choice of biomaterial directly affects the incidence of PCO, underscoring its importance in IOL design and manufacturing.8,9 Furthermore, sharp-edge optic designs have been associated with reduced posterior capsule opacification by limiting lens epithelial cell migration.10,11 These design and material features are therefore relevant when evaluating the postoperative performance of a specific IOL platform. Stable positioning of the IOL within the capsular bag is another important determinant of postoperative optical performance. Clinically relevant IOL tilt or decentration may induce higher-order aberrations and reduce image quality, even when standard distance visual acuity appears acceptable.4,7 Therefore, assessment of IOL position, including clinically detectable tilt and decentration, is relevant when evaluating postoperative outcomes after implantation of an aspheric monofocal IOL. In addition to advancements in materials and lens designs, the emergence of injectable IOL delivery systems has been a pivotal step forward. A major innovation in this domain is the development of preloaded injectable IOL delivery systems.12 These systems offer several potential benefits, including reduction of variability in injector loading, prevention of potential loading errors, and reduction of surgical time.13 However, delivery-system-specific outcomes, such as injection time, injector handling, cartridge behavior, incision enlargement, and surgeon-rated handling, are distinct from postoperative visual and anatomical outcomes. These procedural parameters were collected prospectively as part of the broader clinical evaluation and will be analyzed separately. The present manuscript therefore focuses specifically on postoperative visual performance, refractive outcomes, contrast sensitivity, posterior capsule opacification, clinically detectable IOL tilt or decentration, discoloration, and higher-order aberrations after implantation of the investigated IOL. Although monofocal hydrophobic aspheric IOLs and preloaded delivery systems are already widely used in clinical practice, clinical data remain useful for newly introduced or device-specific IOL platforms because postoperative outcomes may depend on the specific combination of optic design, material, haptic configuration, and implantation system.14 Therefore, this prospective feasibility study was designed to provide preliminary postoperative clinical data for the OPTIFLEX GENESIS COMFORT NY IOL implanted using its preloaded delivery system. The aim of the present analysis was to evaluate postoperative visual acuity, refractive stability, contrast sensitivity, PCO, clinically detectable IOL tilt or decentration, discoloration, and higher-order aberrations over a 12-month follow-up period.
Materials and Methods
This investigator-initiated, prospective, single-center, open-label feasibility study evaluated postoperative visual, refractive, optical, and anatomical outcomes after unilateral or bilateral implantation of the monofocal aspheric hydrophobic acrylic intraocular lens OPTIFLEX GENESIS COMFORT NY using a preloaded delivery system at Heidelberg University Hospital. 30 patients were enrolled, 20 completed the 12-month follow-up and contributed 22 operative eyes to the per-treatment evaluable analysis. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refraction, and intraocular pressure (IOP) were assessed preoperatively and postoperatively. Contrast sensitivity was assessed postoperatively at 3 and 12 months. Posterior capsule opacification (PCO), IOL tilt, decentration, discoloration, and higher-order aberrations were evaluated during follow-up, with PCO, IOL position, and discoloration assessed at the 12-month visit.
The present manuscript focuses specifically on postoperative visual performance, refractive outcomes, contrast sensitivity, IOP, PCO, clinically detectable IOL tilt or decentration, discoloration, and higher-order aberrations.
As this was an exploratory feasibility study, it was not designed or powered as a randomized comparative efficacy trial. The planned enrollment of 30 subjects was selected to provide preliminary prospective safety and postoperative performance data for this specific IOL platform and to support the interpretation of visual, refractive, optical, and anatomical outcomes over the 12-month follow-up period. Therefore, the sample size was considered appropriate for the feasibility nature of the present analysis. No formal comparative success threshold was prespecified for this analysis. Feasibility and safety were interpreted descriptively based on completion of scheduled follow-up assessments, postoperative visual and refractive outcomes, IOP, contrast sensitivity, PCO, clinically detectable IOL position, higher-order aberrations, and the adverse-event profile.
The study was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-392/2011) and registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien; reference number: DRKS00007837). The study was conducted in accordance with the Declaration of Helsinki.
Patients
Patients were recruited between December 2019 and September 2022 at the Department of Ophthalmology, Heidelberg University Hospital, Germany. Inclusion criteria comprised patients aged over 18 years with an axial length between 22 and 25 mm, clear intraocular media apart from cataract, availability for follow-up, sufficient cognitive awareness to comply with examination procedures, and provision of written informed consent for participation and data protection. Written informed consent was obtained from all participants prior to study inclusion.
The exclusion criteria included corneal astigmatism greater than 1.00 D, surgical complications, glaucoma, amblyopia, corneal pathology, history of uveitis, diabetic retinopathy, pseudoexfoliation syndrome, macular pathology, previous intraocular surgery or traumatic cataract, instability of keratometry or biometry measurements, irregular astigmatism, systemic steroid usage, pregnancy, lactation, and concurrent participation in another drug or device evaluation. The study was conducted in compliance with ICH-GCP guidelines, ISO 14155 standards, the Medical Device Directives of the Global Harmonization Task Force and the European Union, and all applicable local confidentiality and data protection regulations.
Objectives
The primary objective of the present analysis was to evaluate postoperative visual and refractive outcomes after implantation of the OPTIFLEX GENESIS COMFORT NY IOL, including UDVA, CDVA, refraction, contrast sensitivity, and higher-order aberrations.
The secondary objective was to evaluate safety and anatomical outcomes by monitoring adverse events and serious adverse events, IOP, PCO, clinically detectable IOL tilt, decentration, discoloration, and other postoperative findings during the 12-month follow-up period.
Intraocular Lens
The OPTIFLEX GENESIS COMFORT NY, manufactured by Biotech Meditech Inc. in Roscommon, Ireland, is a preloaded monofocal hydrophobic acrylic intraocular lens featuring an aspheric optic and a 360-degree sharp-edge design. The material specifications include UV and blue-light filters.
Surgical Procedure and the Postoperative Examinations
All surgeries were performed by two surgeons, GUA and RK. Patients underwent standard cataract surgery with in-the-bag implantation of the study IOL using its preloaded injector system.
Preoperative biometry was performed using the IOLMaster 700 (Carl Zeiss Meditec, Jena, Germany). IOL power was calculated using the Haigis formula, with a target refraction of 0.00 D.
All subjects enrolled in the study underwent clinical follow-up at 1 day, 3 months, and 12 months postoperatively. During these visits, patients received standard postoperative evaluations, including slit-lamp examination, IOP measurement, and visual acuity testing. Visual acuity testing was conducted under photopic conditions using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (Precision Vision, Woodstock, Illinois, USA), with results reported as logarithm of the minimum angle of resolution (logMAR).
At the 3-month follow-up visit, assessments included manifest refraction, monocular and binocular UDVA, CDVA, IOP, contrast sensitivity, and higher-order aberrations. At the 12-month follow-up, manifest refraction, UDVA, CDVA, IOP, contrast sensitivity, and higher-order aberrations were repeated. Contrast sensitivity was measured at spatial frequencies of 3, 6, 12, and 18 cycles per degree using the CSV-1000 chart (VectorVision, Greenville, OH, USA) under photopic and mesopic conditions, with and without glare. Testing was performed at a distance of 2.5 meters using the manifest refraction obtained at 4 meters.
Additional evaluations at 12 months included slit-lamp assessment of posterior capsular opacification and IOL characteristics, including clinically detectable tilt, decentration, and discoloration. PCO was clinically evaluated by slit-lamp examination and subjectively graded as none, minimal, mild, moderate, or severe. IOL tilt, decentration, and discoloration were clinically assessed and recorded as present or absent.
Higher-order aberrations were assessed using the iTrace system. Reported aberration parameters included corneal and total higher-order aberrations, including vertical trefoil, vertical coma, horizontal coma, horizontal trefoil, spherical aberration, and root mean square values of third- to sixth-order higher-order aberrations. The iTrace measurements were performed according to the manufacturer’s standard acquisition protocol.
Adverse events and serious adverse events, including their frequency, severity, and relationship to the study device or procedure, were documented throughout the study period.
Statistical Analysis
Statistical analyses were performed using SPSS statistical software (version 26.0, IBM Corp., Armonk, NY, USA). Continuous variables were summarized using descriptive statistics, including means, standard deviations, medians, and ranges, where appropriate. Categorical variables were summarized as frequencies and percentages.
The Safety Population included all subjects enrolled in the study. The Intent-to-Treat (ITT) Population included all enrolled subjects who received the clinical investigation device at the target site. The Per-Treatment Evaluable (PTE) Population included subjects who received the clinical investigation device at the target site, had no major procedural clinical investigation plan deviations, and had available follow-up data. Efficacy analyses were performed using the ITT and PTE populations, while safety analyses were performed using the Safety Population.
Paired t-tests were used to evaluate changes in visual acuity, refraction, IOP, and contrast sensitivity from baseline to postoperative visits. All statistical tests were two-tailed, with a significance level set at p < 0.05. Data normality was assessed using the Shapiro–Wilk test, and non-parametric tests, including the Wilcoxon signed-rank test, were applied when appropriate.
Because the PTE analysis included 20 subjects contributing 22 operative eyes, outcomes were summarized at the eye level, as PCO, IOL tilt, decentration, discoloration, and higher-order aberrations are eye-specific outcomes. We acknowledge that fellow-eye correlation may influence statistical inference when bilateral eyes are included. Therefore, statistical interpretation was performed cautiously in view of the exploratory feasibility design, the small sample size, and the limited number of bilateral cases.
Results
Demographics and Baseline Characteristics
A total of 30 subjects were screened, enrolled, and included in the Safety Population. There were no screen failures and no subjects who passed screening but were not enrolled. The mean age of the enrolled cohort was 68.6 ± 10.68 years, with a range of 50 to 90 years. The cohort consisted of 19 females (63.3%) and 11 males (36.7%).
Of the 30 enrolled subjects, 25 received the investigational IOL and were included in the Intent-to-Treat (ITT) Population. Twenty subjects completed the 12-month follow-up without major procedural clinical investigation plan deviations and contributed 22 operative eyes to the Per-Treatment Evaluable (PTE) Population. Overall, 10 subjects discontinued before study completion: six withdrew consent, two were lost to follow-up, one was discontinued by physician decision, and one was excluded preoperatively. Subject disposition and analysis populations are presented in Table 1.
Table 1.
Subject Disposition and Analysis Populations
| Analysis Step | Subjects, n (%) | Operative Eyes, n | Comment |
|---|---|---|---|
| Enrolled/Safety Population | 30 (100%) | All enrolled subjects | |
| ITT Population | 25 (83.33%) | 27 | Subjects who received the investigational IOL |
| PTE Population | 20 (66.67%) | 22 | Subjects with evaluable follow-up data and no major procedural deviations |
| Completed 12-month follow-up | 20 (66.67%) | 22 | Final evaluable postoperative cohort |
| Discontinued before completion | 10 (33.33%) | 6 withdrawals by subject; 2 lost to follow-up; 1 physician decision; 1 pre-operative exclusion |
Abbreviations: ITT, Intent-to-treat; PTE, per-treatment evaluable; n, subject.
In the PTE operative eyes, the mean ± SD preoperative manifest spherical refraction was 0.148 ± 3.0915 D, the mean refractive cylinder was −0.477 ± 0.4558 D, and the mean spherical equivalent was −0.090 ± 3.1147 D. Patient characteristics of the enrolled Safety Population are presented in Table 2.
Table 2.
Baseline Characteristics of the Safety Population and PTE Operative Eyes
| Characteristic | Population | Value |
|---|---|---|
| Age, years | Safety Population, N = 30 | 68.6 ± 10.68 |
| Sex, female/male | Safety Population, N = 30 | 19/11 |
| Manifest spherical refraction (D) | PTE operative eyes, N1 = 22 | 0.148 ± 3.09 |
| Refractive cylinder (D) | PTE operative eyes, N1 = 22 | −0.477 ± 0.46 |
| Manifest refraction spherical equivalent (D) | PTE operative eyes, N1 = 22 | −0.09 ± 3.11 |
| Intraocular pressure (mmHg) | PTE operative eyes, N1 = 22 | 15.1 (± 2.83) |
Abbreviations: N, number of subjects; N1, number of operative eyes; PTE, per-treatment evaluable; SD, standard deviation; D, Diopters.
Efficacy
Visual Acuity
Corrected Distance Visual Acuity
Visual acuity outcomes are summarized in Table 3 and Table 4. Compared with preoperative values, CDVA improved significantly at postoperative day 1 (p = 0.0142), 3 months (p < 0.0001), and 12 months (p < 0.0001).
Table 3.
Preoperative and Postoperative Visual Acuity CDVA (LogMAR)
| Visit | Statistic | Optiflex Genesis Comfort NY (N = 20) (N1 = 22) |
|---|---|---|
| Pre-Operative Visit | n | 22 |
| Mean ± SD | 0.296 ± 0.2302 | |
| Post-Operative Visit: 1 Day | N | 22 |
| Mean ± SD | 0.158 ± 0.1867 | |
| Post-Operative Visit: 3 Months | n | 22 |
| Mean ± SD | −0.016 ± 0.1045 | |
| Post-Operative Visit: 12 Months | n | 22 |
| Mean ± SD | 0.011 ± 0.0975 |
Abbreviations: n, number of eyes in specified category; N, number of subjects in the PTE population; N1, number of eyes in treatment; PTE, per treatment evaluable; SD, standard deviation; CDVA, corrected distance visual acuity.
Table 4.
Analysis of Change from Baseline of Visual Acuity CDVA
| Visit | Statistic | Optiflex Genesis Comfort NY (N = 20) (N1 = 22) |
|---|---|---|
| CFB to Post-Operative Visit: 1 Day | N | 22 |
| Mean ± SD | −0.138 ± 0.2424 | |
| p-value | 0.0142 | |
| CFB to Post-Operative Visit: 3 Months | n | 22 |
| Mean ± SD | −0.313 ± 0.2677 | |
| p-value | <0.0001 | |
| CFB to Post-Operative Visit: 12 Months | n | 22 |
| Mean ± SD | −0.285 ± 0.2273 | |
| p-value | <0.0001 |
Notes: Pre-Operative visit is considered ad Baseline. CFB = Post Baseline Visit – Baseline Visit. p-value calculated using paired t-test.
Abbreviations: n, number of eyes in specified category; N, number of subjects in the PTE population; N1, number of eyes in treatment; PTE, per treatment evaluable; SD, standard deviation; CDVA = corrected distance visual acuity.
At 3 months postoperatively, the mean ± SD CDVA was −0.016 ± 0.1045 logMAR. At 12 months, the mean ± SD CDVA was 0.011 ± 0.0975 logMAR. These findings indicate sustained improvement in corrected distance visual acuity over the 12-month follow-up period.
Uncorrected Distance Visual Acuity
UDVA outcomes are summarized in Table 5 and Table 6. UDVA improved significantly at all postoperative time points compared with baseline. The mean ± SD UDVA was 0.125 ± 0.1577 logMAR at 3 months and 0.191 ± 0.1620 logMAR at 12 months. Although UDVA remained improved compared with baseline, mean UDVA was slightly lower at 12 months than at 3 months.
Table 5.
Preoperative and Postoperative Visual Acuity UDVA (LogMAR)
| Visit | Category | Optiflex Genesis Comfort NY (N = 20) (N1 = 22) |
|---|---|---|
| Pre-Operative Visit | n | 22 |
| Mean ± SD | 0.640 ± 0.3354 | |
| Median | 0.620 | |
| Post - Operative Visit: 1 Day | n | 22 |
| Mean ± SD | 0.270 ± 0.2157 | |
| Median | 0.200 | |
| Post - Operative Visit: 3 Months | n | 22 |
| Mean ± SD | 0.125 ± 0.1577 | |
| Median | 0.100 | |
| Post - Operative Visit: 12 Months | n | 22 |
| Mean ± SD | 0.191 ± 0.1620 | |
| Median | 0.140 |
Abbreviations: n, number of eyes in specified category; N, number of subjects in the PTE population; N1, number of eyes in treatment; PTE, per treatment evaluable; SD, standard deviation; UDVA, uncorrected distance visual acuity.
Table 6.
Analysis of Change from Baseline of Visual Acuity UDVA
| Visit | Category | Optiflex Genesis Comfort NY (N = 20) (N1 = 22) |
|---|---|---|
| Post-Operative Visit: 1 Day | n | 22 |
| Mean ± SD | 0.270 ± 0.2157 | |
| p-value vs baseline | 0.0003 | |
| Post-Operative Visit: 3 Months | n | 22 |
| Mean ± SD | 0.125 ± 0.1577 | |
| p-value vs baseline | <0.0001 | |
| Post-Operative Visit: 12 Months | n | 22 |
| Mean ± SD | 0.191 ± 0.1620 | |
| p-value vs baseline | <0.0001 |
Notes: Preoperative visit was considered baseline. p-values were calculated using paired t-test and refer to comparison with baseline UDVA.
Abbreviations: UDVA, uncorrected distance visual acuity; PTE, per-treatment evaluable; SD, standard deviation.
An overview of CDVA and UDVA, including standard deviations, at 3 and 12 months postoperatively is presented in Figure 1.
Figure 1.
Standard graphs for the outcomes with the Optiflex Genesis Comfort intraocular lens. The graph comparing CDVA and UDVA (with standard deviations) at 3 and 12 months postoperatively.
Refractive Outcomes
The target refraction was 0.00 D. The mean ± SD spherical equivalent was +0.308 ± 0.5984 D at 3 months and +0.547 ± 0.5180 D at 12 months. Because the intended refractive target was emmetropia, these values suggest a mild postoperative hyperopic tendency. However, changes in spherical equivalent across postoperative time points were not statistically significant.
Formal refractive predictability parameters, including prediction error, absolute prediction error, and the proportion of eyes within ±0.50 D and ±1.00 D of target refraction, were not available from the existing dataset and therefore could not be reported.
Intraocular Pressure (IOP)
The mean ± SD IOP was 15.1 ± 2.83 mmHg preoperatively, 14.1 ± 2.81 mmHg at 3 months, and 13.9 ± 2.05 mmHg at 12 months.
The mean ± SD change in IOP from baseline was −1.0 ± 3.37 mmHg at 3 months and −1.2 ± 3.64 mmHg at 12 months. These changes were not statistically significant, with p-values of 0.1781 and 0.1285 at 3 and 12 months, respectively. An overview of IOP measurements is provided in Table 7.
Table 7.
Summary of IOP (mmHg)
| Visit | Statistic | Optiflex Genesis Comfort NY (N = 20) (N1=22) |
|---|---|---|
| Pre-Operative | n | 22 |
| Mean ± SD | 15.1 ± 2.83 | |
| Median | 15.5 | |
| Min, Max | 10, 20 | |
| Post-Operative Visit: 3 Months | n | 22 |
| Mean ± SD | 14.1 ± 2.81 | |
| CFB to Post-Operative Visit: 3 Months | Mean ± SD | −1.0 ± 3.37 |
| p-value | 0.1781 | |
| Post-Operative Visit: 12 Months | n | 22 |
| Mean ± SD | 13.9 ± 2.05 | |
| CFB to Post-Operative Visit: 12 Months | Mean ± SD | −1.2 ± 3.64 |
| p-value | 0.1285 |
Notes: Pre-Operative visit is considered ad Baseline. CFB = Post Baseline Visit – Baseline Visit. p-value calculated using paired t-test.
Abbreviations: n, number of eyes in specified category; N, number of subjects in the PTE population; N1, number of eyes in treatment; PTE, per treatment evaluable; SD, standard deviation; IOP, intraocular pressure; mmHg, milimetre of mercury.
Contrast Sensitivity
Contrast sensitivity outcomes under photopic and mesopic conditions, with and without glare, are presented in Figure 2. Overall, mean contrast sensitivity values at 3 and 12 months were within the expected range compared with published normative data, except for photopic 12 cpd, where lower values were observed. These findings were interpreted descriptively because of the small sample size.
Figure 2.
Photopic (A) and mesopic (B) contrast sensitivity. The error bars represent ± 1 standard deviation from the mean. The dotted lines represent ± 1 standard deviation from the mean normal values.
High Order Aberration
Higher-order aberration outcomes are summarized in Figure 3. At the 3-month postoperative visit, corneal higher-order aberration values were numerically low. The mean ± SD values for vertical trefoil, vertical coma, horizontal coma, horizontal trefoil, spherical aberration, and RMS of third- to sixth-order HOAs were 0.0230 ± 0.01762 µm, 0.0255 ± 0.01947 µm, 0.0320 ± 0.03764 µm, 0.0272 ± 0.03916 µm, 0.0190 ± 0.02283 µm, and 0.0723 ± 0.05686 µm, respectively.
Figure 3.
Comparison of corneal and total RMS higher-order aberrations (HOAs) at 3 months postoperatively.
Total ocular higher-order aberrations at 3 months postoperatively showed mean ± SD values of 0.0280 ± 0.01911 µm for vertical trefoil, 0.0301 ± 0.02219 µm for vertical coma, 0.0412 ± 0.03025 µm for horizontal coma, 0.0307 ± 0.03540 µm for horizontal trefoil, 0.0174 ± 0.01509 µm for spherical aberration, and 0.0994 ± 0.04799 µm for RMS HOAs.
IOL Tilt, IOL Decentration, IOL Discoloration
The summary of IOL tilt, IOL decentration, and IOL discoloration is provided in Table 8. No clinically detectable IOL tilt, decentration, or discoloration was observed in any of the 22 operative eyes at the 12-month postoperative visit. These findings are reported descriptively and should be interpreted within the limited 12-month follow-up period.
Table 8.
Summary of IOL Tilt (Degree), IOL Decentration, IOL Discoloration
| Visit | Category | Optiflex Genesis Comfort NY (N = 20) (N1 =22) n (%) |
|---|---|---|
| Post- Operative Visit: 12 Months | ||
| IOL Tilt (Degree) | Yes | 0 (0) |
| No | 22 (100) | |
| IOL Decentration | Yes | 0 (0.00) |
| No | 22 (100) | |
| IOL Discoloration | Yes | 0 (0.00) |
| No | 22 (100) | |
Abbreviations: n, number of eyes in specified category; N, number of subjects in the PTE population; N1, number of eyes in treatment; PTE, per treatment evaluable; SD, standard deviation; IOL, intraocular lens.
PCO (Posterior Capsule Opacification)
At the 12-month postoperative visit, PCO was clinically evaluated by slit-lamp examination and subjectively graded as none, minimal, mild, moderate, or severe. In the PTE population, PCO was absent in 15 operative eyes (68.18%), while minimal PCO was observed in 7 eyes (31.82%). No mild, moderate, or severe PCO was recorded. These findings are summarized in Table 9.
Table 9.
Summary of PCO (Posterior Capsule Opacification)
| Visit | Category | Optiflex Genesis Comfort NY (N = 20) (N1 = 22) n (%) |
|---|---|---|
| Post-Operative Visit 12 Months | None | 15 (68.18) |
| Minimal | 7 (31.82) | |
| Mild | 0 (0) | |
| Moderate | 0 (0) | |
| Severe | 0 (0) |
Abbreviations: n, number of eyes in specified category; N, number of subjects in the PTE population; N1, number of eyes in treatment; PTE, per treatment evaluable; SD, standard deviation; PCO, posterior capsule opacification.
Discussion
Nowadays, a wide range of intraocular lenses (IOLs) is available, differing significantly in their optical properties, materials, structure, and handling. The selection of the appropriate IOL should be tailored to the individual needs, expectations, and comorbidities of the patient. The most commonly implanted IOLs are monofocal lenses, which provide excellent visual acuity at a fixed distance without compromising visual quality or contrast sensitivity.1,2 Another significant advancement is the development of preloaded IOL systems. These are injector systems in which the lens is preloaded, eliminating the need for manual loading during surgery. This innovation may reduce loading variability and simplify IOL implantation.9,13
This prospective, single-center feasibility study evaluated the postoperative outcomes of a preloaded, hydrophobic acrylic monofocal IOL (OPTIFLEX GENESIS COMFORT NY) over a 12-month period. The results showed favorable postoperative visual, refractive, and optical outcomes in the evaluable cohort. However, as this was an uncontrolled feasibility study, the findings should be interpreted as preliminary device-specific clinical data rather than as evidence of superiority over other IOLs or delivery systems.
A statistically significant improvement in both uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), measured in logMAR, was observed in the operative eyes from preoperative baseline through the 3-month and 12-month postoperative follow-ups. These improvements are consistent with effective visual rehabilitation after cataract surgery and implantation of an aspheric monofocal IOL. While a mild hyperopic tendency in spherical equivalent was noted over time, it did not reach statistical significance. Nevertheless, this trend should be considered when interpreting the refractive outcomes of the study. These outcomes are broadly consistent with previously reported visual and refractive results after implantation of hydrophobic acrylic and aspheric monofocal IOLs.14,15 Although UDVA and CDVA remained improved compared with baseline, mean values were numerically slightly lower at 12 months than at 3 months. Given the small sample size and exploratory design, this finding should be interpreted descriptively, and its clinical relevance remains uncertain.
Our results are in line with those reported by Latham et al, who evaluated a preloaded monofocal hydrophobic acrylic IOL in 152 eyes and found a statistically significant improvement in mean CDVA from preoperative assessment to 3 months postoperatively.14 Although the study designs and evaluated devices were not identical, this comparison supports that the postoperative visual outcomes observed in the present feasibility study are broadly consistent with published data for similar preloaded monofocal IOL platforms. Similarly, Kretz et al documented significant improvement in both UDVA and CDVA across patients implanted with an aspheric hydrophobic monofocal IOL.16 These parallels support the clinical plausibility of the present findings and show that the visual outcomes observed in this feasibility study are comparable with those reported for similar monofocal IOL platforms.
Intraocular pressure (IOP) remained stable throughout the study period, with no statistically significant variations from baseline at any postoperative time point. These findings suggest that no clinically relevant IOP increase was observed during follow-up in this cohort.
No clinically detectable IOL tilt, decentration, or discoloration was observed in the 22 evaluable operative eyes at the 12-month visit. These findings suggest stable clinical appearance of the implanted IOL during the observed follow-up period. However, because tilt and decentration were assessed clinically and the follow-up period was limited to 12 months, these results should not be interpreted as definitive evidence of long-term positional stability or material integrity.
Posterior capsule opacification (PCO), a frequent postoperative complication, was absent in the majority of eyes, with only minimal PCO observed in the remaining eyes at 12 months. The hydrophobic acrylic material and 360° sharp-edge design are relevant features in the context of PCO prevention.10,11 However, because this study had no comparator group, it cannot prove that these design features directly reduced lens epithelial cell migration or PCO development. The PCO findings should therefore be interpreted descriptively. These results are broadly comparable with findings reported by Zemaitiene et al, who described PCO and IOL clarity outcomes after monofocal IOL implantation.17
Contrast sensitivity testing under photopic and mesopic lighting conditions, including glare, showed values that were generally within the expected range compared with published normative data, except for photopic 12 cpd, where lower values were observed.18,19 These findings suggest acceptable functional visual performance under the tested conditions, but they should be interpreted descriptively due to the limited sample size.
Postoperative measurements of higher-order aberrations (HOAs), including coma and spherical aberration, were numerically low.20 The low RMS values observed for both corneal and total HOAs suggest limited postoperative optical distortion in the evaluated eyes. However, these findings should be interpreted as postoperative optical-quality parameters and not as isolated proof of IOL-specific optical performance, because corneal and total aberration measurements may be influenced by several ocular factors. The observed HOA values are nevertheless consistent with reports describing low aberration values after implantation of aspheric monofocal IOLs.4,21
Comparable findings were reported by Rekas and colleagues, who demonstrated that spherical and coma aberrations in eyes implanted with an aspheric IOL closely resembled those of younger phakic eyes.4 Their reported postoperative spherical aberration values and the findings of other studies support the role of aspheric lens technology in reducing postoperative spherical aberration and improving optical quality.6,7 The present findings are consistent with these reports, while acknowledging that the lack of a comparator group limits conclusions regarding relative optical advantage.
The present study has several limitations. It was an exploratory, single-center feasibility study with a small sample size and no comparator group. In addition, 10 of 30 enrolled subjects discontinued before completion, which may introduce attrition bias. The PTE analysis included 20 subjects contributing 22 operative eyes; therefore, possible fellow-eye correlation cannot be fully excluded. The 12-month follow-up period is adequate for preliminary assessment of visual acuity, refraction, IOP, early PCO, clinically detectable IOL position, and discoloration, but it does not allow definitive conclusions regarding long-term material stability, long-term PCO prevention, or uncommon safety events. Furthermore, formal refractive predictability parameters, including prediction error, absolute prediction error, and proportions of eyes within ±0.50 D and ±1.00 D of target refraction, were not available from the existing dataset. Therefore, the findings should be interpreted as preliminary device-specific postoperative feasibility data.
Conclusion
The implantation of the OPTIFLEX GENESIS COMFORT NY IOL was associated with favorable postoperative visual and refractive outcomes over a 12-month follow-up period in this prospective single-center feasibility study. Among the 22 evaluable operative eyes, visual acuity improved after surgery, intraocular pressure remained stable, and contrast sensitivity and higher-order aberration findings indicated acceptable postoperative optical performance.
At 12 months, no clinically detectable IOL tilt, decentration, or discoloration was observed, and PCO was absent or minimal in all evaluable eyes. These findings support the preliminary clinical performance of this hydrophobic acrylic aspheric monofocal IOL in the investigated cohort.
However, the results should be interpreted in light of the exploratory design, small sample size, lack of comparator group, and limited follow-up duration. Larger controlled studies with longer follow-up are warranted to confirm these findings, further evaluate refractive predictability, patient-reported outcomes, long-term PCO development, material stability, and delivery-system-specific performance.
Data Sharing Statement
The datasets created and analyzed during the current study available from the corresponding author on reasonable request, [O.H.].
Disclosure
Ramin Khoramnia reports Support for the manuscript from Biotech, during the conduct of the study; Grants or contracts from 1stQ, Alcon, J&J, Carl Zeiss, Hoya, Ophtec; Honoraria from 1stQ, Alcon, Biotech, J&J, Carl Zeiss, Hoya, Ophtec; Meeting/travel support from Alcon, J&J, Hoya; Leadership or fiduciary roles from DGII, SAG, outside the submitted work. Gerd Auffarth reports Support for the manuscript from Biotech, during the conduct of the study; Grants or contracts from 1stQ, Teleon, Stroma, Santen, Refocus, Rayner, Presbia, Ophthamo Pro, Kowa, Hoya, Alcon, AMO/Johnson&Johnson, Carl Zeiss, Contamac, Cristalens, Elios, EyeD, Eyedeal, Fluoron, Oculus, Haag Streit, Hanita; Consulting fees from Alcon, AMO/Johnson und Johnson, Carl Zeiss, Elios, Hanita, Rayner; Honoraria from Afidera, Alcon, AMO/Johnson&Johnson, Carl Zeiss, Eyebright, Elios, Haag Streit, Hanita, Oculus, Rayner, Teleon; Meeting/travel support from Alcon, AMO/Johnson&Johnson, Carl Zeiss, Hanita, Rayner, Teleon, outside the submitted work. The authors report no other conflicts of interest in this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets created and analyzed during the current study available from the corresponding author on reasonable request, [O.H.].