Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-05-30

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.

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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.

Conditions

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Refractive Errors Cataract

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PEX

42 eyes with PEX syndrome and coexisting cataract

Phacoemulsification cataract surgery

Intervention Type PROCEDURE

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.

Control

38 eyes with cataract only

Phacoemulsification cataract surgery

Intervention Type PROCEDURE

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.

Interventions

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Phacoemulsification cataract surgery

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes