Back to resultsSurgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.
Primary Purpose
Idiopathic Epiretinal Membrane, Cataract
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Surgery with and without the aid of Indocyanine Green (ICG)
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Epiretinal Membrane, Cataract focused on measuring Indocyanine green, toxicity, epiretinal membrane, visual field defect
Eligibility Criteria
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.
Sites / Locations
- Dept. of Ophthalmology, University of Regensburg
Outcomes
Primary Outcome Measures
The main outcome measure was improvement of best-corrected visual acuity (BCVA).
Secondary Outcome Measures
Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane
Full Information
NCT ID
NCT00376857
First Posted
September 13, 2006
Last Updated
September 13, 2006
Sponsor
University of Regensburg
1. Study Identification
Unique Protocol Identification Number
NCT00376857
Brief Title
Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.
Official Title
Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
University of Regensburg
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Epiretinal Membrane, Cataract
Keywords
Indocyanine green, toxicity, epiretinal membrane, visual field defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Surgery with and without the aid of Indocyanine Green (ICG)
Primary Outcome Measure Information:
Title
The main outcome measure was improvement of best-corrected visual acuity (BCVA).
Secondary Outcome Measure Information:
Title
Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Hillenkamp, MD
Organizational Affiliation
Dept. of Ophthalmology, University of Regensburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Parykshit Saikia, MD
Organizational Affiliation
Dept. of Ophthalmology, University of Regensburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helmut G Sachs, MD
Organizational Affiliation
Dept. of Ophthalmology, University of Regensburg
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Ophthalmology, University of Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17186261
Citation
Hillenkamp J, Saikia P, Herrmann WA, Framme C, Gabel VP, Sachs HG. Surgical removal of idiopathic epiretinal membrane with or without the assistance of indocyanine green: a randomised controlled clinical trial. Graefes Arch Clin Exp Ophthalmol. 2007 Jul;245(7):973-9. doi: 10.1007/s00417-006-0485-1. Epub 2006 Dec 21.
Results Reference
derived
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Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.
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