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

Idiopathic Epiretinal Membrane, Cataract Clinical Trial

Official title:

Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376857
• Other study ID #: 03123
• Status: Completed
• Phase: N/A
• First received: September 13, 2006
• Last updated: September 13, 2006

Study information

• Verified date: September 2006
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane
• Idiopathic Epiretinal Membrane, Cataract

Intervention

Drug:
• Surgery with and without the aid of Indocyanine Green (ICG)

Locations

Country	Name	City	State
Germany	Dept. of Ophthalmology, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main outcome measure was improvement of best-corrected visual acuity (BCVA).
Secondary	Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane