Abstract
Background/Aim
To evaluate the influence of preoperative dry eye disease (DED) on the postoperative outcome of second generation keratorefractive lenticule extraction (KLEx) surgery.
Patients and Methods
A retrospective cohort study was performed and patients who received second generation KLEx surgery were enrolled. After the categorization, a total of 76, 59, and 65 eyes were put into the non-DED, DED without artificial tear (AT), and DED with AT groups, respectively. The primary outcomes were the uncorrected distance visual acuity (UDVA), spherical equivalent (SE), and postoperative complications. The one-way ANOVA was applied for the statistical analysis.
Results
One day postoperatively, the DED without AT group demonstrated a significantly worse UDVA compared to the other two groups (p=0.002). At the final visit, the UDVA in this group was not significantly lower from that in the non-DED and DED with AT groups (p=0.129). The SE was significantly higher in the DED without AT group than the other two groups from postoperatively day one through three months (all p<0.05). Moreover, the change in UDVA over time was significantly greater in the DED without AT group than in the other two groups (p=0.007). Regarding the vector analysis, the difference vector (DV), correction index (CoI), and angle of error (AE) was significantly higher in the DED without AT group compared to the other two groups (all p<0.05). The rate of postoperative superficial keratitis and DED was significantly higher in the DED without AT group compared to the other two groups (both p<0.05).
Conclusion
The presence of preoperative DED is associated with worse postoperative UDVA recovery and refraction of second generation KLEx surgery, which can be prevented by preoperative AT application.
Keywords: Keratorefractive lenticule extraction, visumax 800, uncorrected distance visual acuity, spherical equivalent, dry eye disease
Introduction
The keratorefractive surgeries have been utilized for the correction of refractive errors involving myopia, astigmatism hyperopia, and presbyopia for decades (1,2). In recent years, the keratorefractive lenticule extraction (KLEx) has gain popularity compared to other keratorefractive surgeries due to the small corneal incision and the lower rate of postoperative dry eye disease (DED) (3-5). The second generation KLEx surgery, an innovation based on the first generation KLEx surgery, was introduced for about two years and the postoperative uncorrected visual acuity can achieve 20/20 in most cases (6). In addition, the postoperative residual refractive error following second generation KLEx surgery was lower than 0.50 diopter (D) in most cases (7).
Despite the generally good efficiency and predictability of the first and second generation KLEx surgery (8), poor postoperative outcomes may still occur (9). In the previous study, the loss of corrected distance visual acuity (CDVA) may develop after the first generation and second generation KLEx surgeries (9,10). Besides, the residual refractive error, mainly myopia and astigmatism, may reduce the visual performance after KLEx surgery and an enhancement procedure may be performed to elevate the visual acuity (3,11). Except for the above two complications, superficial keratitis is another postoperative complication of KLEx surgeries although the incidence is low (12). Also, the severe complication of keratorefractive surgery, like the deep lamellar keratitis, can develop in the KLEx surgery according to an earlier publication (13).
The DED can affect the clinical outcome of kerato-refractive surgery such as laser in situ keratomileusis (14). Regarding KLEx surgery, the preoperative DED status can influence the postoperative UDVA of the first generation KLEx surgery under low antioxidant conditions (15). Nevertheless, there is rarity of studies evaluating whether the preoperative DED would affect postoperative outcomes of the second generation KLEx surgery. In addition, preoperative supplementation of artificial tear (AT) may reduce the influence of preoperative DED on keratorefractive surgery, highlighting the need for further study.
As a consequence, the aim of the current study was to investigate the effect of preoperative DED on the postoperative outcomes of second generation KLEx surgery. Patients with preoperative DED were further analyzed based on whether or not they used AT prior to surgery.
Patients and Methods
Ethics declaration. The current study obeyed the declaration of Helsinki in 1964 and the succeeding amendments. Also, the current study was approved by the Institutional Review Board of National Changhua University of Education (project code: NCUEREC-113-063). The necessity of written informed consents was waived by the Institutional Review Board because of the retrospective design.
Subject selection. A retrospective cohort study was conducted in the Nobel Eye Institute, which is a clinic group that mainly operates the keratorefractive surgery and the cataract surgery. The patients with the following criteria were selected into the study group: 1) myopia status ranged from -1.00D to -9.00D, 2) astigmatism less than -5.00D, 3) received second generation KLEx surgery in any branch of the Nobel Eye Institute, and 4) followed up for at least three months in any branch of the Nobel Eye Institute. In addition, the following exclusion criteria were applied to standardize the clinical features of the study population: 1) aged lower than 20 years or older than 50 years, 2) the receipt of monovision (planned residual myopia) management, and 3) the presence of previous glaucoma, uveitis, ptosis, retinal diseases except retinal break, kertoconus and subclinical keratoconus status, corneal opacity, congenital cataract and optic neuropathy. The study population was then divided into those with and without preoperative DED. Preoperative DED was defined as a Schirmer I test result of less than 10 mm, as previously described (16). In the next step, the patients with preoperative DED were further categorized into the AT group and non-AT group based on the application of preoperative AT. One AT (Systane Hydration, Alcon, Fort Worth, TX, USA) was applied to the patients scheduled for the second generation KLEx surgery preoperatively in our institution. The decision to prescribe AT before surgery was based on the patient’s subjective symptoms; artificial tears were recommended during the initial assessment if any DED-related symptoms - such as dryness, grittiness, foreign body sensation, or burning - were reported. Notably, only the right eye of each patient was included in the current study. After the selection process, 76, 59, and 65 eyes were included in the non-DED group, the DED without AT group, and the DED with AT group, respectively, all of which underwent second-generation KLEx surgery.
Surgery technique. All the second generation KLEx surgeries in the current study were performed by two experienced refractive surgeons (C.-K.C. and C.-Y.L.). The second generation KLEx surgery was completed using a femtosecond laser device (Visuamax 800, Carl Zeiss, Jena, Germany). The range of optic zone of second generation KLEx surgery was 5.5-6.9 mm, and a 3.0 mm incision was at 105 degrees. The angle kappa is determined by the program of Visuamax 800 based on the data from an optical biometry (IOL Master 700, Carl Zeiss), and the coaxial sight corneal light reflex approach and corneal topography were applied to further refine the corneal centration. After the centration process, the whole cornea was fixated using a suction ring and the femtosecond laser emitted after confirmation by the surgeon. After the creation of corneal lenticule, the ophthalmologist utilized a specialized dissector to separate the upper and lower interfaces of corneal lenticule, and the corneal lenticule was removed using forceps. After the surgery, the levofloxacin and prednisolone eye drops were utilized for one week, then switched to sulfamethoxazole and fluorometholone eye drops for three weeks. Preservative-free artificial tears were applied for two weeks following second-generation KLEx surgery, followed by preservative-containing artificial tears for an additional two months.
Operative exam. All the patients received second generation KLEx surgery took the same tests in all branches of Nobel Eye Institute. The preoperative tests included corrected distance visual acuity (CDVA), cyclopegia refraction (sphere power and cylinder power) via a autorefractor (KR-8900, Topcon, Itabashi-ku, Tokyo, Japan), central corneal thickness (CCT), corneal cylinder power, angle kappa, and pupil diameter using a topographic machine (TMS-5, Tomey Coporation, Nagoya, Aichi, Japan), and angle kappa via a biometry machine (IOL Master 700, Carl Zeiss). The Schirmer I test without topical anesthesia was completed preoperatively. The postoperative tests involved the UDVA and refraction examination by the same instruments as the preoperative tests, and the CDVA was recorded three months after the refractive surgery. Regarding the surgical indexes, the cap thickness, optic zone, and the residual stromal thickness (RST) were obtained. The medical records preoperatively, one day postoperatively, one week postoperatively, one month postoperatively, and three months postoperatively were acquired. For the ophthalmic parameters, the spherical equivalent (SE) was defined as the sphere power plus half cylinder power in the current study, and the postoperative DED was defined as the superficial puntate keratitis or DED-related symptoms (i.e., dryness, gritty, foreign body sensation, burning sensation, etc.) after the second generation KLEx surgery. Also, the angle kappa value is the mean value of topographic angle kappa and biometric angle kappa.
Statistical analysis. The SPSS version 20.0 (SPSS Inc., Chicago, IL, USA) was practiced for analysis of the current study. The Shapiro-Wilk test was practiced to examine the normality of our study population and normal distributions were deduced for all indexes (all p>0.05). The statistical power of the current study was 0.96, with the alpha value of 0.05 and a medium effect size, which was yielded by G∗power version 3.1.9.2 (Heinrich Heine Universität, Düsseldorf, Germany).The descriptive analysis was practiced to demonstrate the age, sex, cycloplegia refraction, topographic data and surgical indexes among the three groups, and the Fisher’s exact test and one-way ANOVA was practiced to examine the difference of these indexes among the three groups according to the features of each factor. The one-way ANOVA was also performed to evaluate the postoperative UDVA, SE and CDVA among the non-DED, DED without AT and DED with AT groups in different periods. For the changes of UDVA and SE during the postoperative period, the generalized estimate equation was practiced to examine the difference between the three groups with the adjustments for sex, age, and preoperative cycloplegia refraction. Besides, the vector analysis via the Alpins method was practiced to evaluate the target-induced astigmatism (TIA), magnitude of error (ME), difference vector (DV), surgically induced astigmatism (SIA), correction index (CoI), and angle of error (AE) between the three groups using one-way ANOVA. The presentation of TIA, SIA and DV was according to the arithmetic mean. Finally, the significant postoperative complications were also obtained, and the Fisher’s exact test was practiced to determine the rate of postoperative complications among the three groups. A p-value <0.05 was described as statistical significant, and a p-value over 0.999 was described as p>0.999 while a p-value under 0.001 was described as p<0.001.
Results
The baseline features of the three groups are demonstrated in Table I. The mean age was 34.28±9.57, 35.81±8.26 and 34.77±9.97 years in the non-DED, DED without AT and DED with AT groups, respectively. The differences in mean ages among the three groups were not significantly different (p=278). The sex distributions among the three groups also presented insignificant difference (p=0.082). Except for the Schrimer test value (p<0.001), the values of ophthalmic parameters and the surgical indexes were not significantly different between the three groups (all p>0.05) (Table I).
Table I. Baseline features among the three groups.
AT: Artificial tear; CDVA: corrected distance visual acuity; CCT: central corneal thickness; DED: dry eye disease; N: number; SE: spherical equivalent; RST: residual stromal thickness. *Significant difference between the two groups. aSimilar value in these groups.
One day postoperatively, the mean UDVA was 0.20±0.10, 0.27±0.12 and 0.21±0.12 in the non-DED, DED without AT and DED with AT groups, respectively. The DED without AT group demonstrated a significantly worse UDVA than the other two groups (p=0.002). At the final visit, the UDVA in the DED without AT was not significantly lower compared to the other two groups (p=0.129) (Table II). Regarding the refractive outcome, SE was significantly higher in the DED without AT group compared to the other two groups one day after the surgery (p=0.010). After three months, SE was still significantly higher in the DED without AT group than the other two groups (p=0.011) (Table II). In addition, the CDVA showed no significant difference between the three groups (p=0.929) (Table II). The trend of UDVA change in DED without AT group was significantly larger than the other two groups (p=0.007), while SE changes showed a similar trend in the non-DED, DED without AT and DED with AT groups (p=0.638).
Table II. Postoperative uncorrected distance visual acuity and spherical equivalent among the three groups.
AT: Artificial tear; D: diopter; DED: dry eye disease; SE: spherical equivalent; UDVA: uncorrected distance visual acuity. *Significant difference among groups. aSimilar value of these groups.
About the vector analysis, the DV, CoI and AE were significantly higher in the DED without AT group compared to the other two groups (all p<0.05) while other parameters demonstrated similar values between the three groups (all p>0.05) (Table III). Regarding the postoperative complications, the rate of postoperative superficial keratitis and DED was significantly higher in the DED without AT group compared to the other two groups (both p<0.05). The percentages of other postoperative complications were not significantly different between the three groups (all p>0.05) (Table IV).
Table III. The vector analysis of astigmatism in the three groups.
AE: Angle of error; AT: artificial tear; CoI: correction index; DED: dry eye disease; DV: difference vector; ME: magnitude of error; N: number; SIA: surgically induced astigmatism; TIA: target-induced astigmatism. *Significant difference among groups. aSimilar value of these groups.
Table IV. Postoperative complication among the three groups.
AT: Artificial tear; DED: dry eye disease. *Significant difference among groups. aSimilar value of these groups.
Discussion
In the current study, the postoperative UDVA was significantly worse in the DED population without AT usage compared to other two groups that received second generation KLEx surgery. In addition, the SE and cylinder power was significantly higher in the DED without AT population than the non-DED and DED with AT populations. Furthermore, the DED without AT population demonstrated higher rate of postoperative superficial keratitis and DED than the other groups.
The existence of DED can alter the ocular surface status and interfere with the surgical results (17). The DED is associated with damage of the corneal and conjunctival epithelium (18), and the release of inflammatory cytokine has also been observed on the ocular surface DED (19). In a preceding article, the expression of C-X-C motif chemokine ligand, interleukin, fibroblast growth factor and matrix metalloproteinase were significantly higher in the tear film of patients with DED than in the general population (20). The damage of ocular surface and the elevation of inflammation cytokine could contribute to instability of tear film thus establishing a vicious cycle of DED (21). The presence of DED and its associated ocular surface damage is related to ocular irritation, visual acuity disruption and instability of refractive status (22). Reduction of visual acuity has been reported in patients with DED, which would influence their life quality (23). Also, the irritation of DED and ocular surface damage may lead to the development of depressive disorder (24). Regarding the influence of DED on the ophthalmic surgery, it may be correlated with the higher frequency of dryness and gritty in those received trabeculectomy with functioning blebs (25). Besides, the visual recovery of cataract surgery would be deferred by the pre-existing DED (26), and the quality of vision after cataract surgery would also be affected by the DED (27). In the field of keratorefractive surgery, the emergence of severe DED is a relative contraindication for keratorefractive surgery (28). In addition, the refractive predictability of keratorefractive surgery may be reduced by the presence of DED (29). Because DED can affect the outcomes of several ophthalmic surgeries including the keratorefractive surgery, we hypothesized that the presence and the management of DED would also influence the outcome of newly-developed second generation KLEx surgery. The concept was supported by the results of the current study.
The presence of preoperative DED is associated with worse postoperative UDVA of second generation KLEx surgery in the earlier phase compared to those without DED and those with DED who receive preoperative AT treatment. In a previous study, the postoperative condition and outcome of laser in situ keratomileusis was worse in those diagnosed with DED (30). Besides, the postoperative UDVA of first generation KLEx surgery was also disturbed in those with preceding DED than the non-DED individuals (15,31). Still, there was rarity in evaluating the influence of DED on the surgical outcome of the new generation keratorefractive surgery. To our knowledge, our study is the first to show the negative effect of preoperative DED on the postoperative UDVA of second generation KLEx surgery. In addition, the patients who received second generation KLEx surgery used the same postoperative management protocol in our institution, thus postoperative care may not have affected the outcome. Furthermore, the baseline data, including the age, sex, and ophthalmic statuses, which can affect the results, were grossly similar between the three groups (32), and the confounding effect of preoperative factors might be minimal. The only different preoperative parameter was the Schirmer test result, which represents the condition (i.e., DED) under evaluation. As a consequence, the preoperative DED may be an independent risk factor for the poor postoperative UDVA recovery of second generation KLEx surgery. The final UDVA was not significantly different between the three groups, which may indicate that the preoperative DED did not influence the midterm to long-term UDVA. However, the overall recovery amplitude of DED without AT group was larger than that of the other two groups, which may result from the worse initial postoperative UDVA. According to the above results, the DED without AT individuals may show slower UDVA recovery after second generation KLEx surgery.
Regarding the postoperative refractive status, a higher SE value was observed in the DED without AT group compared to the non-DED group and DED with AT group. In a previous study, the postoperative refraction of cataract surgery may have been influenced by the pre-existing DED (33), but there was a paucity of studies examining the correlation between preoperative DED and the mid-term postoperative refractive status of second generation KLEx surgery. The SE change was regarded as the predictability index of the refractive surgery (34), and the results of the current study may imply that the predictability of second generation KLEx surgery would be decreased by the DED existence. In contrast to the postoperative UDVA, the postoperative SE was still significantly different between the DED without AT group and the other two groups three months postoperatively. This may indicate that the preoperative DED indeed contributed to the higher residual refractive error rather than a transient corneal irregularity. If we separated the SE, the main residual refractive error was the residual myopia in the DED without AT group. Still, the residual myopia degree was approximately -0.40D in the DED without AT group, which may also be an acceptable value compared to earlier study (10). Regarding the postoperative astigmatism, the level of residual astigmatism was similar between the groups while the direction of astigmatism correction was worse in the DED with AT group than the other two groups. This result indicates that preoperative DED has a minor influence on astigmatism correction of second generation KLEx surgery. However, the DED with AT group showed a similar postoperative SE compared to the non-DED group, which imply the usage of AT can reverse the negative effect of preoperative DED on predictability of refractive surgery. Because repeated measurement of refraction would be performed after the initial assessment in our institution, the usage of AT may lead to better refractive status in the following evaluation and enhance the precision of target refraction.
Concerning the safety aspect of the second generation KLEx surgery in different populations, the postoperative CDVA, which was measured three months after the second generation KLEx surgery revealed insignificant differences between the three groups. The CDVA was regarded as a safety index for the refractive surgery in a previous article (35), and the similar CDVA between the three groups shows that the preoperative DED did not diminish the safety of second generation KLEx surgery despite the lower efficiency (the visual acuity) and predictability (the refractive status). Regarding the postoperative complications, the DED without AT group demonstrated a higher risk of developing superficial keratitis and postoperative DED than the other groups. The superficial keratitis is commonly associated with DED (36), and preoperative DED is a known risk factor for postoperative dryness of ophthalmic surgery (37). Accordingly, it is reasonable that the preoperative DED status associated with the above two complications. Similar to the visual and refractive results, the DED patients with preoperative AT management did not show higher superficial keratitis and postoperative DED rates compared to the non-DED population. These findings further highlight the importance of the preoperative AT application for DED patients. The AT used in the current study contains hyaluronic acid and was proven to suppress the DED more effectively than other ATs (38), which may be another reason for the fair superficial keratitis and postoperative DED rates in the DED with AT group. The other postoperative complications appeared at a low incidence in the three groups, thus the quality of second generation KLEx surgery in our institution may be acceptable.
Study limitations. First, the retrospective design of the current study would diminish the homogeneity of our study population compared to a prospective study despite the baseline characteristics were similar among the three groups. Second, we only judged DED according to the preoperative Schirmer test results, which is not an official diagnostic criterion for the DED and may interfere the integrity of our analysis and results. Moreover, the patient numbers in the current study were relatively low in which only 200 eyes were enrolled into the study population and statistical bias cannot be excluded. Finally, all the patients in the current study were Han Taiwanese, thus the external validity and the value of the current study may be relatively inadequate.
Conclusion
In conclusion, the presence of DED would influence the efficiency and predictability of second generation KLEx surgery. Furthermore, the preoperative application of AT could reduce such negative. Consequently, the utilization of AT might be recommended for the patients scheduled for second generation KLEx surgery once DED-related sign or symptom exists. Further large-scale prospective studies are needed to evaluate the optimal dose and type of AT for the improvement of second generation KLEx surgery outcomes in DED population.
Conflicts of Interest
The Authors have no proprietary or commercial interest in any materials mentioned in this article.
Authors’ Contributions
Conceptualization: C.-K.C.; methodology: S.-F.Y. and C.-K.C.; software: C.-K.C.; formal analysis: J.-Y.H.; data curation: I.-B.L. and H.-C.C.; writing - original draft preparation: C.-Y.L.; writing - review and editing: C.-K.C.; visualization, C.-K.C.; validation: C.-K.C.; supervision: C.-K.C. All Authors have read and agreed to the submitted version of the manuscript.
Funding
None.
Artificial Intelligence (AI) Disclosure
No artificial intelligence (AI) tools, including large language models or machine learning software, were used in the preparation, analysis, or presentation of this manuscript.
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