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Sponsors and Collaborators: |
Glostrup University Hospital,Copenhagen Danish Eye Health Society The Danish Medical Research Council |
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Information provided by: | Glostrup University Hospital,Copenhagen |
ClinicalTrials.gov Identifier: | NCT00302328 |
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 |
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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: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Clinical Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes |
Estimated Enrollment: | 80 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | January 2008 |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Department of Ophthalmology, Glostrup Hospital | |
Copenhagen, Denmark, DK-2600 |
Study Director: | Morten la Cour, MD,DMSc,EBOD | Glostrup Hospital, Department of Ophthalmology |
Study Director: | Michael Larsen, MD, DMSc | Glostrup Hospital, Department of Ophthalmology |
Study ID Numbers: | COMAH |
Study First Received: | March 13, 2006 |
Last Updated: | March 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00302328 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Eye Diseases Retinal Perforations Retinal Diseases |
Eye Diseases Retinal Perforations Retinal Diseases |