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CompletedNCT03453827Updated Mar 8, 2018

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

An observational study in Cataract, Pseudoexfoliation Syndrome and Pseudophakia, sponsored by Hospital Hietzing. Completed. Open to participants aged 18 Years to 125 Years. Per ClinicalTrials.gov, last updated 2018-03-08.

Sponsored by Hospital Hietzing · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
37
Ages
18 Years to 125 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract
  • Pseudoexfoliation Syndrome
  • Pseudophakia

Keywords

  • Pseudoexfoliation Syndrome
  • Cataract
  • Aberration
  • IOL decentration
  • IOL tilt
03

Who can participate

Ages eligible
18 Years to 125 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Diabetic retinopathy
  • Age related macula Degeneration
  • retinal bloodvessel disease
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • PEX

    Patients after Cataract surgery with PES

    Other: no intervention

  • Control

    Patients after Cataract surgery without PES

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

05

What researchers measure

Primary outcomes

  1. IOL decentration

    decentration of IOL is measured using Hoya iTrace

    Time frame: 4-6 years after cataract surgery

  2. IOL tilt

    tilt of implanted IOL is measured using Hoya iTace

    Time frame: 4-6 years after cataract surgery

  3. IOL decentration

    decentration of IOL is measured using Zeiss OCT

    Time frame: 4-6 years after cataract surgery

  4. IOL tilt

    tilt of implanted IOL is measured using Zeiss OCT

    Time frame: 4-6 years after cataract surgery

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03453827
Lead sponsor
Hospital Hietzing
Responsible party
Kata Mihaltz (Oberarzt M.D. PhD FEBO, Hospital Hietzing) — Principal investigator
First posted
Mar 5, 2018
Start date
Apr 1, 2016
Primary completion
Apr 28, 2017
Completion
Apr 28, 2017
Last update
Mar 8, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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