NCT02617147

Brief Summary

The purpose of this study is to assess the influence of vitrectomy on changes in central choroidea and comparing the results in imaging of the choroidea with two different OCT devices. This is a prospective, open, non-randomized, observational, MPG study This study will be performed at the Department of Ophthalmology, Medical University of Vienna. 40 Patients who undergo vitrectomy will be included into this study. The investigation will help to gain new information about the effects of vitrectomy on the choroid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

June 16, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

November 24, 2015

Last Update Submit

October 15, 2019

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • choroidal thickness using 2 different OCT devices

    3 months

Secondary Outcomes (1)

  • Visual Acuity using Snellen charts

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with epiretinal membrane scheduled to undergo vitrectomy

You may qualify if:

  • Patients with epiretinal membrane scheduled to undergo vitrectomy without endotamponade
  • Male or female, at least 18 years of age
  • Written informed consent has been obtained
  • Visual acuity ≥0.4

You may not qualify if:

  • Any abnormalities preventing reliable measurements as judged by the investigator
  • Participation in a clinical trial in the 3 weeks preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Medical University of Vienna, Austria

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoz. Prof. Priv. Doz. Dr.

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 30, 2015

Study Start

June 16, 2014

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations

AU(1)