NCT01069029CompletedNot Applicable
Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery
Centre Hospitalier Universitaire Dijon1 site in 1 country120 target enrollmentStarted: January 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Post surgical procedure assessment of Visual acuity
Study Overview
Brief Summary
The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.
Detailed Description
Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Macular Hole Stage 2,3,and 4
- •Visual loss
- •At least 18 years of age
Exclusion Criteria
- •Stage of Macular Hole Stage 1
- •Macular hole post traumatism or associated with retinal detachment
- •Diabetic retinopathy
- •Age-related macular degeneration
- •Myopia > 6 diopters
- •Preoperative pseudophakia
Outcomes
Primary Outcomes
Post surgical procedure assessment of Visual acuity
Time Frame: 6 and 12 months post surgery
Secondary Outcomes
- Rate of closure of macular hole by OCT(at 6 and 12 months post surgery)
Investigators
Study Sites (1)
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