Outcome of Idiopathic Macular Hole
July 16, 2009 updated by: Centre Hospitalier Universitaire Dijon
Long-term Outcome of Idiopathic Macular Hole Surgery
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
135
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Burgundy
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Dijon, Burgundy, France, 21000
- Ophthalmology Unit CHU Dijon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
One hundred and thirty patients (135 eyes) with stage 2, 3, or 4 IMH were included after successful IMH repair
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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vitrectomy in pseudophakic eyes
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vitrectomy and cataract:combined procedure
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vitrectomy followed by cataract extraction
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vitrectomy on phakic eyes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Long-term outcome of idiopathic macular hole surgery
Time Frame: 37 months
|
37 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Catherine Creuzot-Gracher, MD, PhD, Ophthalmology Unit CHU Dijon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion
December 7, 2022
Study Completion (Actual)
January 1, 2005
Study Registration Dates
First Submitted
March 30, 2009
First Submitted That Met QC Criteria
July 16, 2009
First Posted (Estimate)
July 17, 2009
Study Record Updates
Last Update Posted (Estimate)
July 17, 2009
Last Update Submitted That Met QC Criteria
July 16, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Macular hole 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.