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Macular Function After Scleral Buckle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345007
First Posted: June 27, 2006
Last Update Posted: June 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Singapore National Eye Centre
  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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00345007     History of Changes
Other Study ID Numbers: R414/09/2005
First Submitted: June 26, 2006
First Posted: June 27, 2006
Last Update Posted: June 27, 2006
Last Verified: May 2005

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

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases