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Macular Function After Scleral Buckle

This study has been completed.
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00345007
First received: June 26, 2006
Last updated: NA
Last verified: May 2005
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
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

No publications provided

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

Keywords provided by Singapore National Eye Centre:
Retinal detachment
Macular function
Multifocal electrophysiology

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013