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

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ClinicalTrials.gov Identifier: NCT03453827
Recruitment Status : Completed
First Posted : March 5, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Kata Mihaltz, Hospital Hietzing

Brief Summary:
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.

Condition or disease Intervention/treatment
Cataract Pseudoexfoliation Syndrome Pseudophakia Other: no intervention

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.

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Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients who underwent standard procedure cataract surgery with or without Pseudoexfoliation Syndrome.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Kata Mihaltz, Oberarzt M.D. PhD FEBO, Hospital Hietzing
ClinicalTrials.gov Identifier: NCT03453827     History of Changes
Other Study ID Numbers: PEX Study
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kata Mihaltz, Hospital Hietzing:
Pseudoexfoliation Syndrome
Cataract
Aberration
IOL decentration
IOL tilt
Additional relevant MeSH terms:
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Cataract
Exfoliation Syndrome
Syndrome
Pseudophakia
Disease
Pathologic Processes
Lens Diseases
Eye Diseases
Iris Diseases
Uveal Diseases
Signs and Symptoms