NCT00376857

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
Last Updated

September 15, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2006

Last Update Submit

September 13, 2006

Conditions

Idiopathic Epiretinal Membrane, Cataract

Keywords

Indocyanine green, toxicity, epiretinal membrane, visual field defect

Outcome Measures

Primary Outcomes (1)

  • The main outcome measure was improvement of best-corrected visual acuity (BCVA).

Secondary Outcomes (1)

  • Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with IEM and cataract or posterior chamber intraocular lens pseudophakia complaining of loss of visual acuity and metamorphopsia during the past six months.

You may not qualify if:

  • Other retinal disease, non-idiopathic epiretinal membrane, glaucoma or history of retinal detachment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Ophthalmology, University of Regensburg

Regensburg, 93042, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17186261DERIVED

MeSH Terms

Conditions

CataractEpiretinal Membrane

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRetinal Diseases

Study Officials

  • Jost Hillenkamp, MD

    Dept. of Ophthalmology, University of Regensburg

    PRINCIPAL INVESTIGATOR

  • Parykshit Saikia, MD

    Dept. of Ophthalmology, University of Regensburg

    PRINCIPAL INVESTIGATOR

  • Helmut G Sachs, MD

    Dept. of Ophthalmology, University of Regensburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Last Updated

September 15, 2006

Record last verified: 2006-09

Locations

DE(1)