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

NCT ID: NCT00376857

Last Updated: 2006-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Epiretinal Membrane, Cataract

Keywords

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Indocyanine green, toxicity, epiretinal membrane, visual field defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regensburg

OTHER

Sponsor Role lead

Principal Investigators

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Jost Hillenkamp, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Ophthalmology, University of Regensburg

Parykshit Saikia, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Ophthalmology, University of Regensburg

Helmut G Sachs, MD

Role: STUDY_CHAIR

Dept. of Ophthalmology, University of Regensburg

Locations

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Dept. of Ophthalmology, University of Regensburg

Regensburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 17186261 (View on PubMed)

Other Identifiers

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03123

Identifier Type: -

Identifier Source: org_study_id