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

NCT ID: NCT03453827

Last Updated: 2018-03-08

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

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-04-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract Pseudoexfoliation Syndrome Pseudophakia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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PEX

Patients after Cataract surgery with PES

no intervention

Intervention Type OTHER

no intervention

Control

Patients after Cataract surgery without PES

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Diabetic retinopathy
* Age related macula Degeneration
* retinal bloodvessel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

125 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Hietzing

OTHER

Sponsor Role lead

Responsible Party

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Kata Mihaltz

Oberarzt M.D. PhD FEBO

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PEX Study

Identifier Type: -

Identifier Source: org_study_id

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