NCT01343134

Brief Summary

The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than 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

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
Last Updated

May 16, 2011

Status Verified

January 1, 2011

Enrollment Period

5 months

First QC Date

April 26, 2011

Last Update Submit

May 12, 2011

Conditions

Rhegmatogenous Retinal Detachment

Keywords

RetinaRhegmatogenous retinal detachmentMacular detachmentSpectral domain OCTMicroperimetry

Study Arms (1)

Retinal detachment cohort

Device: Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)

Interventions

Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)DEVICE

Measure the thickness of the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg)and perform central microperimetry using new OPKO Instruments OCT.

Retinal detachment cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with successful repair of rhegmatogenous retinal detachment after macula off and minimum 6 month follow-up after surgery

You may qualify if:

  • Rhegmatogenous retinal detachment

You may not qualify if:

  • Epiretinal membrane

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department CHU Dijon

Dijon, Burgundy, 21000, France

Location

Study Officials

  • Catherine Creuzot-Garcher, MD;PhD

    Ophthalmology department CHU Dijon

    STUDY DIRECTOR

  • Marie Pierre Delolme, MD

    Ophthalmology Department CHU Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

May 16, 2011

Record last verified: 2011-01

Locations

FR(1)