Status:
COMPLETED
Internal Limiting Membrane Peeling for Large Macular Holes
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Macular Hole
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) p...
Detailed Description
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) p...
Eligibility Criteria
Inclusion
- Age equal to or higher than 18 years
- Patient presenting a TM idiopathic of stage 2, 3 or 4
- Macular hole \> 400 µm in diameter
- Patient having been informed of the objectives and constraints of the study and having signed an informed consent
Exclusion
- Patient age \< 18 years.
- Patient having a strong myopia of the operated eye: correction carried or optimal \>6 dioptres
- Patient MONOPHTHALMIA.
- Patient pseudophakia presenting an "insufficient" plan capsular CRYTALLINE.
- Patient presenting a cataract making impossible a good visualization of the bottom of eye.
- Patient presenting an important opacification capsular.
- Patient presenting an associated ocular pathology being able to interfere with the operation.
- Patient presenting a TM already operated of the eye to include
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00190190
Start Date
January 1 2005
End Date
May 1 2008
Last Update
July 18 2008
Active Locations (1)
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1
Service d'Ophtalmolgie de l'Hôpital Lariboisière
Paris, France, 75010