Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery

March 6, 2018 updated by: Kata Mihaltz, Hospital Hietzing

Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery

To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.

Study Type

Observational

Enrollment (Actual)

37

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 to 125 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent standard procedure cataract surgery with or without Pseudoexfoliation Syndrome.

Description

Inclusion Criteria:

  • patients 4-6 years after standard cataract surgery
  • pseudoexfoliation Syndrome (PES)

Exclusion Criteria:

  • Diabetic retinopathy
  • Age related macula Degeneration
  • retinal bloodvessel disease

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PEX
Patients after Cataract surgery with PES
Other: no intervention
no intervention
Control
Patients after Cataract surgery without PES
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOL decentration
Time Frame: 4-6 years after cataract surgery
decentration of IOL is measured using Hoya iTrace
4-6 years after cataract surgery
IOL tilt
Time Frame: 4-6 years after cataract surgery
tilt of implanted IOL is measured using Hoya iTace
4-6 years after cataract surgery
IOL decentration
Time Frame: 4-6 years after cataract surgery
decentration of IOL is measured using Zeiss OCT
4-6 years after cataract surgery
IOL tilt
Time Frame: 4-6 years after cataract surgery
tilt of implanted IOL is measured using Zeiss OCT
4-6 years after cataract surgery

Collaborators and Investigators

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

Sponsor

Hospital Hietzing

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)

April 1, 2016

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

April 28, 2017

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEX Study

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.

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