Outcome of Idiopathic Macular Hole

Idiopathic Macular Hole Clinical Trial

Official title:

Long-term Outcome of Idiopathic Macular Hole Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941291
• Other study ID #: Macular hole 1
• Status: Completed
• Phase: N/A
• First received: March 30, 2009
• Last updated: July 16, 2009
• Start date: January 2002
• Est. completion date: January 2005

Study information

• Verified date: July 2009
• 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 evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair

Exclusion Criteria:

• All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Idiopathic Macular Hole
• Retinal Perforations

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	Long-term outcome of idiopathic macular hole surgery		37 months	No