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Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Macular Hole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757600
First Posted: December 31, 2012
Last Update Posted: December 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicot Frederic, Centre Hospitalier Universitaire Dijon
  Purpose
To evaluate the correlations between anatomical and functional changes studied with microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of idiopathic macular hole (MH).

Condition Intervention
Macular Hole Other: Microperimetry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long-term Anatomical and Functional Outcomes of Idiopathic Macular Hole Surgery. The Yield of Spectral-domain OCT Combined With Microperimetry.

Further study details as provided by Nicot Frederic, Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Macular sensitivity [ Time Frame: 12 months ]
    To describre mean retinal sensitivity in the 12 and 4 central degrees of the retina in 23 patients one-year after macular hole surgery and thus to correlate macular sensitivities and retinal anatomic features in SD-OCT


Enrollment: 23
Study Start Date: August 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Macular Hole Other: Microperimetry

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent successful surgery for MH defined as closure of the hole, at least 1 year before.
Criteria

Inclusion Criteria:

  • Closure of the hole seen on the OCT at 1 year postoperative

Exclusion Criteria:

  • Patients with an axial length over 26 mm, diabetes, macular diseases, glaucoma, or postoperative retinal detachment were excluded
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757600


Locations
France
Ophthalmology Department CHU Dijon
Dijon, Burgundy, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicot Frederic, Head of research unit in Ophthalmology department, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01757600     History of Changes
Other Study ID Numbers: Arnaud01
First Submitted: December 13, 2012
First Posted: December 31, 2012
Last Update Posted: December 31, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases