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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicot Frederic, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01757600
First received: December 13, 2012
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  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 Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Macular sensitivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757600

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

No publications provided

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
Study First Received: December 13, 2012
Last Updated: December 21, 2012
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013