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CompletedNCT03404323Updated Jan 19, 2018

"Cataract Surgery in Eyes With Epiretinal Membrane"

An observational study in Epiretinal Membrane, Pseudophakic Cystoid Macular Edema and Irvine-Gass Syndrome, sponsored by St John of God Hospital, Vienna. Completed. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by St John of God Hospital, Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.

Read the detailed description

Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.

02

Conditions studied

  • Epiretinal Membrane
  • Pseudophakic Cystoid Macular Edema
  • Irvine-Gass Syndrome
  • Cataract

Keywords

  • central retinal thickness
  • epiretinal membrane
  • cataract surgery
  • pseudophakic cystoid macular edema
03

In context

Epiretinal Membrane

130 studies on the registry are indexed under Epiretinal Membrane; 18 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 48 observational studies indexed under Epiretinal Membrane.

Browse Epiretinal Membrane studies →

Lead sponsor

St John of God Hospital, Vienna is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Thirty patients with visually compromising cataract and asymptomatic epiretinal membrane (ERM group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.

Exclusion criteria

Exclusion Criteria:

  • visual impairment or metamorphopsia due to epiretinal membrane
  • history of branch retinal vein occlusion
  • central retinal vein occlusion
  • wet or dry macular degeneration
  • diabetic retinopathy
  • uveitis or other inflammatory eye disease.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. central macular thickness

    Central 1-millimeter and 3-milimeter retinal thickness

    Time frame: Change from Baseline central macular thickness at 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03404323
Lead sponsor
St John of God Hospital, Vienna
Responsible party
Barbara Wetzel (Principal Investigator, St John of God Hospital, Vienna) — Principal investigator
First posted
Jan 19, 2018
Start date
Jul 1, 2015
Primary completion
Jul 1, 2016
Completion
May 1, 2017
Last update
Jan 19, 2018

Study contacts

Barbara Wetzel, MD
principal investigator · St John of God Hospital, Vienna
Georgios Mylonas, MD
study director · St John of God Hospital, Vienna

Oversight

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

Not currently enrolling

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

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