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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01757600
Other study ID # Arnaud01
Secondary ID
Status Completed
Phase N/A
First received December 13, 2012
Last updated December 21, 2012
Start date August 2010

Study information

Verified date December 2012
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 55 Years to 85 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Microperimetry


Locations

Country Name City State
France Ophthalmology Department CHU Dijon Dijon Burgundy

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Macular sensitivity 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 12 months No
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