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

This study has been completed.
Sponsor:
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00376857
First received: September 13, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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 NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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

No publications provided by University of Regensburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

ClinicalTrials.gov processed this record on June 17, 2013