Viewing Study NCT00345007



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00345007
Status: COMPLETED
Last Update Posted: 2006-06-27
First Post: 2006-06-26

Brief Title: Macular Function After Scleral Buckle
Sponsor: Singapore National Eye Centre
Organization: Singapore National Eye Centre

Study Overview

Official Title: Assessment of Recovery of Macula Function After Successful Scleral Buckling Surgery for Rhegmatogenous Retinal Detachment
Status: COMPLETED
Status Verified Date: 2005-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Assess recovery of macula function after successful scleral buckling surgery for rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period ie recovery of functional integrity 2 Assess the relationship between the neurosensory retina and the retinal pigment epitheliumchoriocapillaris after scleral buckling ie recovery of structural integrity 3 Assess if there is a difference between macula function postoperatively in eyes with retinal detachments involving the macula and those that do not
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 ie 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None