Refractive Outcomes After Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

March 3, 2021 updated by: Medical University of Lublin

Refractive Outcomes of Phacoemulsification Cataract Surgery in Eyes With Pseudoexfoliation Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients above 18 yo with senile cataract with/without PEX without coexisting ocular pathologies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare refractive outcomes in PEX and control eyes.
Time Frame: 3 months
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.
Time Frame: 3 months
To measure the effects of IOL power calculation formulas - SRK/T, Barrett Universal II and Hill-RBF - on postoperative refraction
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Investigators

  • Study Chair: Tomasz Żarnowski, MD, PhD, Professor, Medical University in Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE-0254/241/2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Refractive Errors

Clinical Trials on Phacoemulsification cataract surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe