Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Study Overview
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Brief Summary
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To evaluate the refractive outcomes of cataract surgery in PEX syndrome and determine which of the commonly used IOL formulas (SRK/T, Barrett Universal II and Hill-RBF) is the best in predicting postoperative refractive outcomes in PEX.

Detailed Description
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The primary outcome measure was to compare refractive outcomes (MAE, MedAE, percentage of eyes within certain range of prediction error) in PEX and control eyes. The secondary outcome measure was to determine whether any of IOL power prediction formulas (SRK/T, Barrett Universal II and Hill-RBF) is more precise for these challenging eyes.

Official Title
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Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Conditions
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Refractive Errors, Cataract

Intervention / Treatment
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* Procedure: Phacoemulsification cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: senile cataract with/without PEX Exclusion Criteria: corneal pathology glaucoma, corneal astigmatism greater than 2.0 diopters (D), previous eye surgery or subjects with decreased vision due to other reasons than cataract (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases), intraoperative complications, postoperative corrected distance visual acuity (CDVA) worse than 20/40, axial length below 21 mm and above 25 mm, dense cataracts or poor fixation requiring ultrasound biometry eyes with manifest iridophacodonesis and those in which a capsular tension ring was inserted

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEX<br>42 eyes with PEX syndrome and coexisting cataract | Procedure: Phacoemulsification cataract surgery<br>* All surgeries were performed using Infinity (Alcon Laboratories, Inc.) under topical anaesthesia by one surgeon through 2.2 mm incision in the upper corneal limbus. The hydroimplantation of IOL to the capsular bag was performed in all cases.<br>|
| Control<br>38 eyes with cataract only | Procedure: Phacoemulsification cataract surgery<br>* All surgeries were performed using Infinity (Alcon Laboratories, Inc.) under topical anaesthesia by one surgeon through 2.2 mm incision in the upper corneal limbus. The hydroimplantation of IOL to the capsular bag was performed in all cases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare refractive outcomes in PEX and control eyes. | To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether any of IOL power prediction formulas is more precise for these challenging eyes. | To measure the effects of IOL power calculation formulas - SRK/T, Barrett Universal II and Hill-RBF - on postoperative refraction | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pseudoexfoliation, phacoemulsification cataract surgery, IOL power calculation formulas