MedTrace Logo

Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

NCT00302328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-04-16

Study results available
· View outcomes & findings →

Summary

The project is a randomized clinical trial with a follow up time of 12 months comparing the effects of surgical treatment of idiopathic macular holes. Patients are randomized to vitrectomy alone, vitrectomy plus indocyanine green (ICG) assisted inner limiting membrane ( ILM) peeling or vitrectomy plus trypan blue (tb) assisted ILM peeling. At baseline patients are characterized using early treatment diabetic retinopathy study (ETDRS) visual charts, tests of aniseikonia, optical coherence tomography 3 (OCT3), visual field and fundus photography. Per- and postoperative complications are registered.

Data analyses will help clarify the effect of ILM peeling on hole closure and visual acuity. Comparing results after ICG- and tb assisted ILM peeling will help clarify the topic of a toxic effect on retinal cells after staining and peeling of the ILM. Changes in intraretinal morphology before and after dye-assisted ILM peeling will be studied using OCT3 imaging and the patients' subjective opinion on the surgical results will be analyzed using quality of life questionnaires and metamorphopsia tests.

Conditions

  • Idiopathic Macular Hole

Interventions

PROCEDURE

macular hole operation

macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling

Sponsors & Collaborators

  • Danish Eye Health Society

    collaborator OTHER

  • The Danish Medical Research Council

    collaborator OTHER

  • Glostrup University Hospital, Copenhagen

    lead OTHER

Principal Investigators

  • Morten la Cour, MD,DMSc,EBOD · Glostrup Hospital, Department of Ophthalmology

  • Michael Larsen, MD, DMSc · Glostrup Hospital, Department of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-01-31
Completion
2009-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302328 on ClinicalTrials.gov