NCT01757600

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
Last Updated

December 31, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

December 13, 2012

Last Update Submit

December 21, 2012

Conditions

Macular Hole

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Macular Hole

Other: Microperimetry

Interventions

MicroperimetryOTHER
Macular Hole

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent successful surgery for MH defined as closure of the hole, at least 1 year before.

You may qualify if:

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

You may not qualify if:

  • Patients with an axial length over 26 mm, diabetes, macular diseases, glaucoma, or postoperative retinal detachment were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department CHU Dijon

Dijon, Burgundy, 21000, France

Location

Related Publications (1)

  • Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26.

    PMID: 23620091DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research unit in Ophthalmology department

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 31, 2012

Study Start

August 1, 2010

Primary Completion

November 1, 2010

Last Updated

December 31, 2012

Record last verified: 2012-12

Locations

FR(1)