Abstract
Purpose:
The study aimed to analyze the surgical outcome of manual small incision cataract surgery (MSICS) in patients with pseudoexfoliation syndrome (PXF) and pseudoexfoliation glaucoma (PXG) and compare them with those of controls.
Settings and Design:
This prospective, observational, and comparative study included 150 cases of PXF with cataracts, 150 cases of PXG with cataracts, and 200 cases of cataracts without PXF as controls.
Methods:
MSICS was performed in all cases under peribulbar anesthesia. Intraoperative complications, if any, were noted. Best-corrected visual acuity (BCVA), intraocular pressure (IOP), and postoperative complications were recorded at follow-up on day 1, day 7, and after 1 month.
Statistical Analysis Used:
IBM SPSS 24.0 statistics, SPSS South Asia Pvt Ltd.
Results:
Lines of improvement in BCVA were significantly better in the control group (8.7 ± 1.7) than that in the PXF (7.5 ± 2.1) and PXG groups (6.4 ± 2.7). IOP significantly decreased from baseline to 1 month postoperatively in the PXG group than in the PXF and control groups (mean difference: 3.8 ± 7.5 mm Hg). Intraoperative iridodialysis and zonular dialysis were significantly high in the PXG group with a proportion of 4 and 20%, respectively. Postoperative choroidal detachment and hyphema, six cases each, were found significantly high in the PXG group.
Conclusion:
Although the BCVA improvement was less and the complications were high in patients with pseudoexfoliation, especially those with PXG, the reduction in IOP was significant. MSICS can be considered favorably in patients with PXF and PXG, with adequate precautions to manage anticipated complications.
Keywords: Manual small incision cataract surgery, pseudoexfoliation glaucoma, pseudoexfoliation syndrome
Pseudoexfoliation syndrome (PXF) is an age-related idiopathic clinical entity.[1,2] This systemic microfibrilopathy has a predilection for ocular tissue which is clinically diagnosed by the presence of greyish-white, flaky, and dandruff-like deposits called pseudoexfoliation material, preferably accumulating on the anterior surface of the lens capsule and the pupillary border of the iris and clogs trabecular meshwork.[3] Its most important clinical implication is the increased predisposition for the development of secondary open-angle glaucoma called pseudoexfoliation glaucoma (PXG), zonular weakness, and poor mydriasis.[4]
The most common presenting feature in PXF and PXG is visual impairment due to cataracts. PXF is an independent risk factor for the development of nuclear sclerosis and an indication for cataract surgery.[5] Cataract surgery primarily aims at improving visual acuity, and previous studies have also established the supplemental role to reduce intraocular pressure (IOP) in both open and closed-angle glaucoma.[6,7]
In patients with pseudoexfoliation, the inherent elasticity of lens capsules and zonules gets reduced, thereby exacerbating intraoperative and postoperative complications. The devastating complications are zonular dialysis (ZD), capsulotomy or capsulorhexis extension, posterior capsular rupture (PCR), and nucleus drop, which can remarkably influence the post-surgical outcome.[8] In addition to intraoperative complications, postoperative issues such as high postoperative IOP spikes, iris vascular leak, and compromised blood-aqueous barrier should be considered.[9]
The optimal surgical approach for cataracts in a patient with co-existing glaucoma and pseudoexfoliation remains uncertain. Several studies have revealed the surgical outcome of phacoemulsification in patients with PXF,[10,11,12,13,14] however, studies on manual small incision cataract surgery (MSICS) are still rare. MSICS is an alternative to phacoemulsification in settings with high surgical volume or regions with limited access in rural or semi-urban India. It is significantly faster, requires minimal instrumentation, and can be performed in all settings.[15] It is a safe and effective alternative to phacoemulsification, even in patients with uveitis with no significant difference in complications and final visual outcomes.[16] Therefore, this study aimed to develop insights into better cataract management in patients with PXF and PXG by evaluating the MSICS procedure.
Methods
This was a hospital-based prospective, observational, and comparative study conducted at a tertiary eye care center in eastern India, from February 2017 to March 2018. The study was approved by the Institutional Ethics Committee. Informed consent was obtained from all patients. The study was conducted according to the principles of the Declaration of Helsinki. The confidentiality of patients was maintained at all stages of the data analysis.
The study included patients over the age of 40 years who came to the hospital through cataract screening camps or outpatient departments with visually significant cataract. After assigning a registration number, the demographic profile of each patient was recorded. Detailed systemic and treatment history were taken. Best-corrected visual acuity (BCVA) was recorded using the Snellen chart. An ocular evaluation was performed using a slit-lamp biomicroscope, with both diffuse and slit beams. Gonioscopy was performed to evaluate the anterior chamber angle status. Intraocular pressure (IOP) was recorded using a regularly calibrated Goldman’s applanation tonometer (GAT) and corrected with central corneal thickness. Visual field analysis was performed using Humphrey Perimeter (Carl Zeiss Meditec AG, Jena, Germany) with a 24-2 testing strategy for patients with high IOP and/or suspected glaucomatous optic disc changes.
Mydriasis was achieved by applying 0.8% tropicamide and 5% phenylephrine eye drops. The diameter of the dilated pupil was measured with the help of slit-lamp beam height and a pupil of <5 mm was considered as poor, 5–6 mm as mid, and ≥7 mm as good pupillary dilatation. The anterior lens capsular surface was examined using both diffuse and slit beams at low and high magnification to detect pseudoexfoliation. Cataract was classified as immature cataract, mature, or cataract with phacodonesis. Fundus evaluation was performed using a slit-lamp biomicroscope and 90 D lens after pupillary dilatation. Color and size of the disc, depth of the cup, vertical cup-to-disc ratio (VCDR), status of the neuroretinal rim (NRR), configuration of vessels, and appearance of nerve fiber layer in red free light were observed.
The study participants were assigned to two groups. Patients with pseudoexfoliation over the lens or pupillary ruff were classified as cases, while those without pseudoexfoliation were classified as controls. Cases with no evidence of glaucomatous optic nerve damage or visual field defect were categorized into the PXF group, whereas those with evidence of glaucomatous optic nerve damage (VCDR ≥0.7, cup-to-disc asymmetry of >0.2 between two eyes, focal notching or rim loss, or a combination of these) and field defects corresponding to disc damage were assigned to the PXG group. Patients with no clinically evident pseudoexfoliation, baseline IOP of <21 mm Hg, and normal disc and visual field were classified as the control group. Patients with inaccurate light perception and projection of rays, any corneal or retinal pathology precluding reliable tonometry, visual field, and disc examination, those with narrow-angle (Shaffer grade ≤ 2) or on any antiglaucoma medication, and those with a history of any ocular surgery or trauma were excluded from the study.
All patients were operated on by surgeons well-versed in MSICS, under peribulbar anesthesia. Following the preparation of a superior fornix-based conjunctival flap, a 6–8 mm frown incision was fashioned 2 mm behind the limbus, followed by a partial thickness sclera tunnel. A side port was performed at the 9 o’clock position, with a 24G lance tip. The anterior chamber was entered centrally using a 3.2 mm keratome through the sclera tunnel. Trypan blue was used to make the anterior capsule visible. The anterior chamber was filled with 2% hydroxy propyl methyl cellulose and continuous curvilinear capsulorhexis was performed using a 26G bent cystitome. After the extension of the wound, a gentle hydro dissection was performed to prolapse the nucleus into the anterior chamber. The nucleus was subsequently delivered using wire Vectis. Cortical material was cleared using the irrigation-aspiration cannula, and a single-piece polymethyl methacrylate posterior chamber intraocular lens was implanted. Complete removal of viscoelastic from the anterior chamber by irrigation-aspiration was performed. The irrigating solution used was a sterile ophthalmic balanced salt solution in all cases. Reformation of the anterior chamber and stromal hydration of the side port was ensured at the conclusion of surgery. A subconjunctival injection of gentamicin 20 mg and dexamethasone 2 mg was subsequently given. Intraoperative complications if any and the appropriate surgical strategies followed to handle the complications were observed. On the first postoperative day and at subsequent check-ups after 1 week and 1 month, BCVA, IOP, and any encountered complications were recorded. Lines of improvement in visual acuity, IOP changes at different follow-ups, and complications if any following the surgical procedure were compared between the groups.
Statistical analysis
Statistical analysis was performed using IBM SPSS 24.0 statistics (SPSS South Asia Pvt. Ltd). Comparison of visual acuity in terms of mean lines of improvement and mean IOP change at different follow-ups between the groups was performed using one-way analysis of variance (ANOVA) techniques, followed by posthoc Bonferroni test for multiple comparisons of pairs of groups. The relationship between preoperative and postoperative complications was analyzed using the cross-tabulation procedure, followed by a Chi-square test of independence. A P- value of ≤0.05 was considered statistically significant.
Results
To analyze the surgical outcomes in the PXF and PXG groups, data were collected from the three groups of patients: groups1, 2, and 3 comprising 150 cases of PXF with cataracts, 150 cases of PXG with cataracts, and 200 cases of cataracts, respectively. To analyze the outcomes in the three groups, four characteristics were considered, such as the improvement in visual acuity, change in IOP, and intraoperative and postoperative complications.
Comparison of visual acuity
Visual acuity was compared by observing the lines of improvement from preoperative visual acuity at different follow-ups. It was observed that in all three groups, there was a gradual increase in the mean lines of improvement from day 1 until 1 month [Table 1]. However, improvement was consistently better in the control group, with a range of 7.1 ± 2.2 to 8.7 ± 1.7, followed by the PXF group with a range of 5.7 ± 2.5 to 7.5 ± 2.1. In the PXG group, the improvement was lower than that of the control and PXF groups, ranging from 5.0 ± 3.2 on day 1 to 6.4 ± 2.7 in 1 month. There was a significant difference in mean lines of improvement among the three groups (P = 0.000) at all follow-ups. The highest and least improvement were noticed in the control and PXG groups, respectively.
Table 1.
Mean lines of improvement in visual acuity among the groups
| Lines of improvement at follow-up visit | Pseudoexfoliation syndrome (n=150) | Pseudoexfoliation glaucoma (n=150) | Control (n=200) | ANOVA P |
|---|---|---|---|---|
| Day 1 | 5.7±2.5 | 5.0±3.2 | 7.1±2.2 | 0.000 |
| 1 week | 7.3±2.0 | 6.2±3.2 | 8.3±1.9 | 0.000 |
| 1 month | 7.5±2.1 | 6.4±2.7 | 8.7±1.7 | 0.000 |
The pairwise multiple comparisons in the line of improvement between each pair are presented in Table 2. At 1 week, the PXF group had significantly higher mean lines of improvement in visual acuity than the PXG group, whereas the control had the highest mean lines of improvement (P = 0.000). At 1 month, the control group had the highest mean lines of improvement in visual acuity followed by PXF and PXG groups (P = 0.000).
Table 2.
Multiple comparisons of the mean line of improvement in visual acuity among the groups
| Dependent variable | Group |
Mean difference (I−J) | SE | P | |
|---|---|---|---|---|---|
| I | J | ||||
| Lines of improvement | Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | 0.64 | 0.30 | 0.104 |
| Day 1 | Control | −1.45 | 0.28 | 0.000 | |
| Pseudoexfoliation glaucoma | Control | −2.09 | 0.28 | 0.000 | |
| Lines of improvement | Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | 1.08 | 0.27 | 0.000 |
| 1 week | Control | −1 | 0.26 | 0.000 | |
| Pseudoexfoliation glaucoma | Control | −2.08 | 0.26 | 0.000 | |
| Lines of improvement | Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | 1.04 | 0.25 | 0.000 |
| 1 month | Control | −1.26 | 0.23 | 0.000 | |
| Pseudoexfoliation glaucoma | Control | −2.3 | 0.23 | 0.000 | |
Comparison of postoperative IOP
At baseline (preoperative), the PXF, PXG, and control groups had mean IOPs of 15.5 ± 2.5, 25.5 ± 6.9, and 15.3 ± 2.9 mm Hg, respectively. Comparison of mean IOP levels across the three groups at different follow-ups [Table 3] showed the mean IOP between the PXF and control groups was comparable, while the PXG group had significantly higher IOP (P = 0.000) at baseline. At subsequent follow-ups, the PXG group had significantly higher mean IOP than that of the PXF and control groups. The mean IOP in the PXF group increased from 15.5 ± 2.5 mm Hg at baseline to 16.9 ± 2.3 mm Hg at 1 month of follow-ups. The difference was −1.47 ± 2.64 (P = 0.000). In the PXG group, the mean IOP decreased from 25.5 ± 6.9 mm Hg to 21.7 ± 3.7 mm Hg at 1 month. The decline was 3.8 ± 7.59 (P = 0.000). In the control group the mean IOP was 15.3 ± 2.9 mm Hg at baseline and 15.5 ± 2.3 mm Hg at 1 month. The difference was −0.21 ± 1.97 (P = 0.133).
Table 3.
Comparisons of mean IOP among the groups
| Pseudoexfoliation syndrome (n=150) | Pseudoexfoliation glaucoma | Control (n=200) | ANOVA P | |
|---|---|---|---|---|
| Pre-op | 15.5±2.5 | 25.5±6.9 | 15.3±2.9 | 0.000 |
| Day 1 | 16.7±3.9 | 22.3±4.6 | 16.3±3.4 | 0.000 |
| 1 week | 15.9±2.7 | 21.3±4.4 | 15.7±2.3 | 0.000 |
| 1 month | 16.9±2.3 | 21.7±3.7 | 15.5±2.3 | 0.000 |
| Preop to postop 1 month | −1.47±2.64 | 3.8±7.59 | −0.21±1.97 | |
| Paired “t” test Mean difference±SD | ||||
| P | 0.000 | 0.000 | 0.133 |
Multiple comparisons of mean IOP by pairs of groups in Table 4 revealed that the mean IOP in the PXG group was significantly higher compared to the other two groups (P = 0.000). However, the mean IOP did not differ significantly among the PXF and control groups.
Table 4.
Multiple comparisons of mean IOP among the groups
| Dependent variable | Group |
Mean difference (I−J) | SE | P | |
|---|---|---|---|---|---|
| I | J | ||||
| Intraocular pressure preop | Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | −10.05 | 0.51 | 0.000 |
| Control | 0.18 | 0.48 | 1.000 | ||
| Pseudoexfoliation glaucoma | Control | 10.23 | 0.48 | 0.000 | |
| Intraocular pressure Day 1 |
Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | −5.65 | 0.45 | 0.000 |
| Control | 0.33 | 0.42 | 1.000 | ||
| Pseudoexfoliation glaucoma | Control | 5.98 | 0.42 | 0.000 | |
| Intraocular pressure 1 week |
Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | −5.47 | 0.37 | 0.000 |
| Control | 0.11 | 0.34 | 1.000 | ||
| Pseudoexfoliation glaucoma | Control | 5.58 | 0.34 | 0.000 | |
| Intraocular pressure 1 month |
Pseudoexfoliation syndrome | Pseudoexfoliation glaucoma | −4.79 | 0.32 | 0.000 |
| Control | 1.43 | 0.30 | 0.000 | ||
| Pseudoexfoliation glaucoma | Control | 6.22 | 0.30 | 0.000 | |
Intraoperative complications
Table 5 presents intraoperative complications by groups. In the PXF group, there were two cases each (1.3%) of IOL drop, iridodialysis, and nucleus drop. Moreover, there were eight cases (5.3%) of PCR and ZD each. In the PXG group, IOL drop was observed in one case (0.7%), iridodialysis in six cases (4%), and a nucleus drop in two cases (1.3%). The proportion of PCR was 8% (12 cases) and ZD was 20% (30 cases) in the PXG groups. In the control group, PCR was observed in six cases (3%) and ZD in four cases (2%), and there were no cases of IOL drop, iridodialysis, and nucleus drop in this group. Among the three groups, the PXG group has a significantly high incidence of iridodialysis (P = 0.012) and ZD (P = 0.000).
Table 5.
Comparison of intraoperative complications among the groups
| Intraoperative complications | Pseudoexfoliation syndrome |
Pseudoexfoliation glaucoma |
Control |
χ2, P | |||
|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | ||
| IOL drop | 2 | 1.3 | 1 | 0.7 | 0 | 0 | χ2=2.571, P=0.277 |
| Iridodialysis | 2 | 1.3 | 6 | 4.0 | 0 | 0 | χ2=8.808, P=0.012 |
| Nucleus drop | 2 | 1.3 | 2 | 1.3 | 0 | 0 | χ2=2.688, P=0.261 |
| Posterior capsule rupture | 8 | 5.3 | 12 | 8.0 | 6 | 3 | χ2=4.355, P=0.113 |
| Zonular dialysis | 8 | 5.3 | 30 | 20.0 | 4 | 2 | χ2=38.712, P=0.000 |
Postoperative complications
Comparative analysis of complications found during follow-up after surgery [Table 6] showed anterior chamber (AC) reaction, striate keratopathy (SK), and microcystic corneal edema (MCE) had no statistical relationship between the three groups. Choroidal detachment (CD) was observed in six cases (4%) in the PXG group. No CD was observed in the other two groups. This relationship was statistically significant (P = 0.001). Hyphema was significantly high in the PXG group as it was observed in six cases (4%), whereas two cases (1%) in the control group, and no case in the PXF group.
Table 6.
Comparison of postoperative complications among the groups
| Postoperative complications | Pseudoexfoliation syndrome |
Pseudoexfoliation glaucoma |
Control |
χ2, P | |||
|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | ||
| Anterior chamber reaction | 4 | 2.7 | 5 | 3.3 | 6 | 3 | χ2=0.115, P=0.944 |
| Striate keratopathy | 24 | 16.0 | 30 | 20.0 | 26 | 13 | χ2=3.125, P=0.210 |
| Microcystic corneal edema | 8 | 5.3 | 12 | 8.0 | 14 | 7 | χ2=0.863, P=0.650 |
| Choroidal detachment | 0 | 0.0 | 6 | 4.0 | 0 | 0 | χ2=14.170, P=0.001 |
| Hyphema | 0 | 0.0 | 6 | 4.0 | 2 | 1 | χ2=8.384, P=0.015 |
Discussion
Although the improvement of VA was seen postoperatively in all patients in our study, the improvement was significantly less in the PXF and PXG groups, as compared to the control group, during the early postoperative period. This was attributed to higher intraoperative manipulation, early postoperative inflammation, and corneal edema in these groups. By the end of one month, the improvement in VA was comparable between PXF and control groups. This was due to the resolution of inflammation and corneal edema. These results were comparable with the studies conducted by Shastri et al.,[14] Sufi et al.,[17] and Akinci et al.,[18] who reported no significant difference in VA between the PXF and control groups at 6 months. However, in the PXG group, this improvement was significantly less at 1 month, attributed to high rates of intraoperative and postoperative complications.
The mean IOP of the PXF, PXG, and control groups at baseline in our study was 15.5 ± 2.5, 25.5 ± 6.9, and 15.3 ± 2.9 mm Hg, respectively. This was consistent with the findings of Rao et al.,[19] and Shingleton et al.[20] This implies that eyes with PXG require evaluation and reducing IOP preoperatively is essential to reducing complications. Our study findings revealed that there was a significant decline in IOP from baseline at postoperative one month in the PXG group. The mean difference of IOP in the PXG group was comparable to a similar study performed by Damji et al.[21]
In this study, intraoperative complications like IOL drop, iridodialysis, nucleus drop, PCR, and ZD were found more frequently in the PXF and PXG groups as compared to the control. Moreover, there were significant numbers of iridodialysis (6 cases), PCR (12 cases), and ZD (30 cases) observed in the PXG group. This indicates a higher rate of complications in patients with pseudoexfoliation, especially in PXG cases. Our findings correlated with the findings of Sufi,[17] Naik,[22] and Sastry.[23]
There was no statistically significant difference in the occurrence of SK, MCE, and AC reactions between the three groups in this study because we did not grade these complications. However, the incidence of CD and hyphema in six cases each was significantly high in the PXG group.
In our study, the PXG group, followed by the PXF group, was associated with a higher rate of intraoperative and postoperative complications, as well as a lesser improvement of visual acuity. Thus, all patients with PXF and PXG should receive detailed counseling about cataract surgery with its possible outcomes, and warning about these adverse outcomes following surgery.
Limitations
The main limitation of our study was the short follow-up period. Long-term follow-up is required to observe improvement in visual acuity, changes in IOP, and late complications. The cataract surgeries were performed by different surgeons. Hence, the outcome of this study may have been subjected to some degree of selection bias.
Conclusion
The association of pseudoexfoliation with cataracts may affect visual prognosis. The improvement of visual acuity in the PXG group was less compared to the PXF group and the control. The PXG group exhibited a significant postoperative reduction of IOP. This helps in better postoperative control of IOP with less medication. Many devastating intraoperative and postoperative complications can be anticipated in cases of pseudoexfoliation, with PXG being highly associated with such complications. These complications can have a remarkable impact on cataract surgery outcomes. Hence, proper preoperative evaluation, appropriate surgical strategies, and adequate preparation for the timely management of predictable complications may result in favorable surgical outcomes in pseudoexfoliation, particularly in PXG.
Financial support and sponsorship:
Nil.
Conflicts of interest:
There are no conflicts of interest.
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