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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Glostrup University Hospital, Copenhagen.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Danish Eye Health Society

The Danish Medical Research Council

Information provided by:

Glostrup University Hospital, Copenhagen

ClinicalTrials.gov Identifier:

NCT00302328

First received: March 13, 2006

Last updated: September 3, 2009

Last verified: September 2009

History of Changes

Purpose

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 ICG-assisted ILM peeling or vitrectomy plus Trypanblue-assisted ILM peeling. At baseline patients are characterized using ETDRS visual charts, tests of aniseikonia, OCT3, autoperimetri 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 Trypanblue-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.

Condition	Intervention
Idiopathic Macular Hole Stage 2 and 3	Procedure: Vitrectomy without ILM peeling Procedure: Vitrectomy with ICG-assisted ILM peeling Procedure: Vitrectomy with Trypanblue assisted ILM peeling

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:

Visual Acuity

Secondary Outcome Measures:

Anatomic Success
Visual field defects
Metamorphopsia
Retinal Pigmentepitelium Atrophy
Intraretinal Morphological Changes
Quality of Life

Estimated Enrollment:	80
Study Start Date:	August 2005
Estimated Study Completion Date:	January 2008

Eligibility

Genders Eligible for Study:

Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302328

Locations

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

Sponsors and Collaborators

Glostrup University Hospital, Copenhagen

Danish Eye Health Society

The Danish Medical Research Council

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

More Information

No publications provided by Glostrup University Hospital, Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Christensen UC. Value of internal limiting membrane peeling in surgery for idiopathic macular hole and the correlation between function and retinal morphology. Acta Ophthalmol. 2009 Dec;87 Thesis 2:1-23.

Krøyer K, Christensen U, la Cour M, Larsen M. Metamorphopsia assessment before and after vitrectomy for macular hole. Invest Ophthalmol Vis Sci. 2009 Dec;50(12):5511-5. Epub 2009 Jul 2.

Christensen UC, Krøyer K, Sander B, Larsen M, Henning V, Villumsen J, la Cour M. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial. Br J Ophthalmol. 2009 Aug;93(8):1005-15. Epub 2008 Nov 21.

Krøyer K, Christensen U, Larsen M, la Cour M. Quantification of metamorphopsia in patients with macular hole. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3741-6. Epub 2008 Apr 30.

ClinicalTrials.gov Identifier:	NCT00302328 History of Changes
Other Study ID Numbers:	COMAH
Study First Received:	March 13, 2006
Last Updated:	September 3, 2009
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:

Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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