- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345007
Macular Function After Scleral Buckle
Assessment of Recovery of Macula Function After Successful Scleral Buckling Surgery for Rhegmatogenous Retinal Detachment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with acute rhegmatogenous retinal detachments managed by scleral buckling surgery will be recruited into 3 groups. (Please see attached appendix A)
We define the area of the macula as the area within the temporal vascular arcades with the horizontal radius defined between the optic disc and the foveal centre.
Group A: Macula not detached Group B: Macula partially detached i.e. detachment stops within the macula Group C: Macula is totally detached
After scleral buckling surgery for the retinal detachment, the patients will be examined at Day 1, week 1, month1, 3 and 6. During these visits, they will be examined clinically, as well as undergo tests - refraction, colour vision (D-15) & contrast sensitivity testing, OCT and multifocal ERG. (Please see attaced visit schedule).
Study Type
Enrollment
Contacts and Locations
Study Locations
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Singapore, Singapore, 168751
- Singapore National Eye Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute rhegmatogenous retinal detachment undergoing scleral buckling surgery
Exclusion Criteria:
- Only eye patients
- Patients who undergo surgery which require use of intravitreal gases
- Patients who will not be able to cooperate for the mfERG and OCT testing
- Patients with macula hole detachments
- Fellow eye with poor vision resulting in inability to fixate for the mfERG
Study Plan
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shu-Yen Lee, FRCSEd, Singapore National Eye Centre
- Study Chair: Chong-Lye Ang, FRCOphth, Singapore National Eye Centre
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R414/09/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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