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NCT01069029 Clinical Trial

Combined Versus Successive Macular Hole and Cataract Surgery

Visual Acuity Clinical Trial

Official title:
Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01069029
Other study ID # Aurore 1
Secondary ID
Status Completed
Phase N/A
First received February 16, 2010
Last updated February 16, 2010
Start date January 2006
Est. completion date December 2007

Study information
Verified date January 2006
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

- Glaucoma

- Age-related macular degeneration

- Myopia > 6 diopters

- Preoperative pseudophakia

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Ophthalmology Unit CHU Dijon Dijon Burgundy

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post surgical procedure assessment of Visual acuity 6 and 12 months post surgery No
Secondary Rate of closure of macular hole by OCT at 6 and 12 months post surgery No
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