Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green. - Full Text View

Sponsored by:	University of Regensburg
Information provided by:	University of Regensburg
ClinicalTrials.gov Identifier:	NCT00376857

Purpose

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.

Condition	Intervention
Idiopathic Epiretinal Membrane, Cataract	Drug: Surgery with and without the aid of Indocyanine Green (ICG)

MedlinePlus related topics: Cataract

Drug Information available for: Indocyanine green

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial

Further study details as provided by University of Regensburg:

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

Estimated Enrollment:

60

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376857

Locations

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

Sponsors and Collaborators

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

More Information

Publications indexed to this study:

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. Epub 2006 Dec 21.

Study ID Numbers:	03123
Study First Received:	September 13, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00376857
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:

Indocyanine green, toxicity, epiretinal membrane, visual field defect

Study placed in the following topic categories:

Eye Diseases
Cataract
Epiretinal Membrane

Lens Diseases
Scotoma
Retinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009