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Completed

NCT Number: NCT03453827

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.

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Key information

Conditions

Cataract Exfoliation Syndrome Eye Diseases Iris Diseases Lens Diseases Pathological Conditions, Signs and Symptoms Pseudoexfoliation Syndrome Pseudophakia Signs and Symptoms Uveal Diseases

Age range

18 year–125 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. IOL decentration

    Time frame: 4-6 years after cataract surgery

    decentration of IOL is measured using Hoya iTrace

  2. IOL tilt

    Time frame: 4-6 years after cataract surgery

    tilt of implanted IOL is measured using Hoya iTace

  3. IOL decentration

    Time frame: 4-6 years after cataract surgery

    decentration of IOL is measured using Zeiss OCT

  4. IOL tilt

    Time frame: 4-6 years after cataract surgery

    tilt of implanted IOL is measured using Zeiss OCT

Sponsors and collaborators

Lead sponsor

Hospital Hietzing

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 5, 2018
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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