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

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ClinicalTrials.gov Identifier: NCT00376857
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : September 15, 2006
Sponsor:
Information provided by:

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The main outcome measure was improvement of best-corrected visual acuity (BCVA).

Secondary Outcome Measures :
  1. Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00376857     History of Changes
Other Study ID Numbers: 03123
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: September 2006

Keywords provided by University of Regensburg:
Indocyanine green, toxicity, epiretinal membrane, visual field defect

Additional relevant MeSH terms:
Cataract
Epiretinal Membrane
Lens Diseases
Eye Diseases
Retinal Diseases