- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00376857
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
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Regensburg, Germany, 93042
- Dept. of Ophthalmology, University of Regensburg
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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 |
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The main outcome measure was improvement of best-corrected visual acuity (BCVA).
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Secondary Outcome Measures
Outcome Measure |
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Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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.
Clinical Trials on Idiopathic Epiretinal Membrane, Cataract
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