Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.

September 13, 2006 updated by: University of Regensburg

Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial

It was the aim of the present study to prospectively compare the functional and morphological outcome of idiopathic epiretinal membrane surgery with and without the assistance of Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual acuity (BCVA). This was treated as an open question and we had no hypothesis which of the two therapies was superior.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93042
        • Dept. of Ophthalmology, University of Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with IEM and cataract or posterior chamber intraocular lens pseudophakia complaining of loss of visual acuity and metamorphopsia during the past six months.

Exclusion Criteria:

  • Other retinal disease, non-idiopathic epiretinal membrane, glaucoma or history of retinal detachment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The main outcome measure was improvement of best-corrected visual acuity (BCVA).

Secondary Outcome Measures

Outcome Measure
Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Jost Hillenkamp, MD, Dept. of Ophthalmology, University of Regensburg
  • Principal Investigator: Parykshit Saikia, MD, Dept. of Ophthalmology, University of Regensburg
  • Study Chair: Helmut G Sachs, MD, Dept. of Ophthalmology, University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 13, 2006

First Submitted That Met QC Criteria

September 13, 2006

First Posted (Estimate)

September 15, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2006

Last Update Submitted That Met QC Criteria

September 13, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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