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

March 13, 2014 updated by: Ulrik Christensen, Glostrup University Hospital, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2600
        • Department of Ophthalmology, Glostrup Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Idiopathic macular hele stage 2 or 3.
  • Duration of Symptoms ≤ 12 months.
  • Visual acuity ≥ 34 ETDRS letters.
  • Intraocular pressure ≤ 23 mmHg.
  • Informed consent.

Exclusion Criteria:

  • Previous macular hole in project eye
  • Macular pucker worse than a cellophane macular reflex.
  • Previous surgery or disease in the eye affecting retinal function.
  • Systemic disease affection vision including diabetes mellitus with level of retinopathy ≥ 14a.
  • Amblyopia i project eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: macular hole operation no peeling
Active Comparator: Macular hole operation ICG peeling
Procedure: macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling
Experimental: Macular hole operation TB peeling
Procedure: macular hole operation
macular hole surgery with either no peeling, indocyanine green (ICG) assisted peeling or trypan blue (tb) peeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity (ETDRS Letters)
Time Frame: Visual acuity at 12 months
Visual acuity measured as the number of ETDRS letters at last follow-up
Visual acuity at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anatomic Success
Time Frame: macular hole closure at 12 months
closure of the macular hole evaluated on optical coherence tomography 3 (OCT3)
macular hole closure at 12 months
Visual Field Defects
Time Frame: 6 months
visual field defects measured on humphrey perimetry
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

The Danish Medical Research Council
Danish Eye Health Society

Investigators

  • Study Director: Morten la Cour, MD,DMSc,EBOD, Glostrup Hospital, department of Ophthalmology
  • Study Director: Michael Larsen, MD, DMSc, Glostrup Hospital, department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria

March 13, 2006

First Posted (Estimate)

March 14, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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