Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Completed

• Conditions: Refractive Errors; Cataract
• Interventions: Procedure: Phacoemulsification cataract surgery

• Registration Number: NCT04783909
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-05-30
• Status Verified: 2021-03
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Last Update Submitted: 2021-03-03
• Study First Posted: 2021-03-05
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Phacoemulsification cataract surgery	38 eyes with cataract only
PEX	Phacoemulsification cataract surgery	42 eyes with PEX syndrome and coexisting cataract

Primary Outcome Measures

Name	Time	Method
To compare refractive outcomes in PEX and control eyes.	3 months	To measure MAE, MedAE, percentage of eyes within certain range of prediction error after cataract surgery

Secondary Outcome Measures

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