Status:
COMPLETED
Trial of Prognostic Factors and Surgical Methods for the Treatment of Idiopathic Macular Holes
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Collaborating Sponsors:
Danish Eye Health Society
The Danish Medical Research Council
Conditions:
Idiopathic Macular Hole
Eligibility:
All Genders
Phase:
NA
Brief 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, vitr...
Eligibility Criteria
Inclusion
- Idiopathic macular hele stage 2 or 3.
- Duration of Symptoms ≤ 12 months.
- Visual acuity ≥ 34 ETDRS letters.
- Intraocular pressure ≤ 23 mmHg.
- Informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00302328
Start Date
August 1 2005
End Date
January 1 2009
Last Update
April 16 2014
Active Locations (1)
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1
Department of Ophthalmology, Glostrup Hospital
Copenhagen, Denmark, DK-2600