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Outcome of Idiopathic Macular Hole

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT00941291
First received: March 30, 2009
Last updated: July 16, 2009
Last verified: July 2009
History of Changes
  Purpose

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).


Condition
Idiopathic Macular Hole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Outcome of Idiopathic Macular Hole Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract Edema
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Long-term outcome of idiopathic macular hole surgery [ Time Frame: 37 months ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: January 2002
Study Completion Date: January 2005
Groups/Cohorts
vitrectomy in pseudophakic eyes
vitrectomy and cataract:combined procedure
vitrectomy followed by cataract extraction
vitrectomy on phakic eyes

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941291

Locations
France
Ophthalmology Unit CHU Dijon
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Catherine Creuzot-Gracher, MD, PhD Ophthalmology unit CHU Dijon
  More Information

No publications provided by Centre Hospitalier Universitaire Dijon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Creuzot-Garcher Catherine
ClinicalTrials.gov Identifier: NCT00941291     History of Changes
Other Study ID Numbers: Macular hole 1
Study First Received: March 30, 2009
Last Updated: July 16, 2009
Health Authority: France: Direction Générale de la Santé

Keywords provided by Centre Hospitalier Universitaire Dijon:
idiopathic macular hole
cataract
edema
Reopening

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013