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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Centre Hospitalier Universitaire Dijon

Additional 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
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
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014