Combined Versus Successive Macular Hole and Cataract Surgery

Completed

• Conditions: Macular Hole; Visual Acuity

• Registration Number: NCT01069029
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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 Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Last Update Submitted: 2010-02-16
• Study First Posted: 2010-02-17
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post surgical procedure assessment of Visual acuity	6 and 12 months post surgery

Secondary Outcome Measures

Name	Time	Method
Rate of closure of macular hole by OCT	at 6 and 12 months post surgery

Trial Locations

Locations (1)

Ophthalmology Unit CHU Dijon; 🇫🇷 Dijon, Burgundy, France