Macular Function After Scleral Buckle

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

Assessment of Recovery of Macula Function After Successful Scleral Buckling Surgery for Rhegmatogenous Retinal Detachment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345007
• Other study ID #: R414/09/2005
• Status: Completed
• Phase: N/A
• First received: June 26, 2006
• Last updated: June 26, 2006
• Start date: June 2005
• Est. completion date: October 2006

Study information

• Verified date: May 2005
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

Procedure:
• Scleral buckling

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore,