Macular Function After Scleral Buckle - Full Text View

Sponsored by:	Singapore National Eye Centre
Information provided by:	Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT00345007

Purpose

Assess recovery of macula function after successful scleral buckling surgery for rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period i.e. recovery of functional integrity 2. Assess the relationship between the neurosensory retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e. 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.

Condition	Intervention
Rhegmatogenous Retinal Detachment	Procedure: Scleral buckling

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Assessment of Recovery of Macula Function After Successful Scleral Buckling Surgery for Rhegmatogenous Retinal Detachment

Further study details as provided by Singapore National Eye Centre:

Estimated Enrollment:	27
Study Start Date:	June 2005
Estimated Study Completion Date:	October 2006

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345007

Locations

Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751

Sponsors and Collaborators

Singapore National Eye Centre

Investigators

Principal Investigator:	Shu-Yen Lee, FRCSEd	Singapore National Eye Centre
Study Chair:	Chong-Lye Ang, FRCOphth	Singapore National Eye Centre

More Information

Study ID Numbers:	R414/09/2005
Study First Received:	June 26, 2006
Last Updated:	June 26, 2006
ClinicalTrials.gov Identifier:	NCT00345007
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by Singapore National Eye Centre:

Retinal detachment
Macular function
Multifocal electrophysiology

Study placed in the following topic categories:

Retinal Detachment
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on January 13, 2009