Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Sponsor

Medical University of Lublin (Other)

Overall Status

Completed

CT.gov ID

NCT04783909

Collaborator

(none)

Enrollment

19.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors Cataract	Procedure: Phacoemulsification cataract surgery

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 Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
PEX 42 eyes with PEX syndrome and coexisting cataract	Procedure: 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.
Control 38 eyes with cataract only	Procedure: 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.

Arm

Intervention/Treatment

PEX

42 eyes with PEX syndrome and coexisting cataract

Procedure: 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.

Control

38 eyes with cataract only

Procedure: Phacoemulsification cataract surgery

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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