Status:
UNKNOWN
Inverted ILM Repositioning as Treatment for Full Thickness Macular Holes
Lead Sponsor:
Military Institute od Medicine National Research Institute
Conditions:
Macular Holes
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of surgical treatment of FTMH using an inverted ILM repositioning to improve anatomical and functional outcomes in patients with a macu...
Detailed Description
At present, the anatomical closure rate of macular hole is around 90% using pars plana vitrectomy with ILM peeling. Improvement of visual acuity is around 80% including stage II to IV. With macular ho...
Eligibility Criteria
Inclusion
- full-thickness macular hole with a minimum diameter exceeding 400 μm
- BCVA of 0,3 or worse in log MAR units (\<=70 ETDRS letter) and 1,6 or better in log MAR units (\>=5 ETRDS letter)
- 18 years of age
- Informed consent
Exclusion
- eyes with previous vitreous surgery
- cystoid macular edema from any cause
- post traumatic macular hole
- macular hole associated with retinal detachment
- any other ocular reason which causes the lack of improvement after macular hole surgery (e.g pigmentary abnormalities, age-related macular degeneration, corneal scarring)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01228188
Start Date
August 1 2010
End Date
August 1 2013
Last Update
October 26 2010
Active Locations (1)
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1
Military Institute of Medcine
Warsaw, Ul. Szaserów 128, Poland, 04-141