NCT03404323

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 11, 2018

Last Update Submit

January 18, 2018

Conditions

Epiretinal MembranePseudophakic Cystoid Macular EdemaIrvine-Gass SyndromeCataract

Keywords

central retinal thicknessepiretinal membranecataract surgerypseudophakic cystoid macular edema

Outcome Measures

Primary Outcomes (1)

  • central macular thickness

    Central 1-millimeter and 3-milimeter retinal thickness

    Change from Baseline central macular thickness at 3 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epiretinal MembraneMacular EdemaCataract

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationLens Diseases

Study Officials

  • Barbara Wetzel, MD

    St John of God Hospital, Vienna

    PRINCIPAL INVESTIGATOR

  • Georgios Mylonas, MD

    St John of God Hospital, Vienna

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

May 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01