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NCT00442156 · ClinicalTrials.gov registry record
The Course of Response to Focal Photocoagulation for DME
A clinical trial, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- 122
- Enrollment target
NCT00442156: Completed study, sponsored by Jaeb Center for Health Research.
NCT00442156 is a clinical trial that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 122 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00442156 has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- 122 participants
- Enrollment target
Study Summary
The study objective is to determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME. The response will be evaluated separately in eyes with and without prior focal photocoagulation for DME. The purpose is to determine the proportion of eyes that continue to improve at least 5 letters in visual acuity or at least 10% in central retinal thickness after a session of focal photocoagulation. In addition, the study will explore whether any baseline factors can be identified that are predictive of the response. All subjects will have follow-up visits 8 weeks and 16 weeks post treatment. At the 16-week visit, study eyes are evaluated for change in retinal thickness and visual acuity from baseline. * Treatment is to be deferred and follow up continued if visual acuity letter score has improved by \>5 or OCT central subfield thickness has decreased by \>10% compared with baseline. * If visual acuity letter score has not improved by at least 5 and OCT central subfield thickness has not decreased by at least 10%, then the eye is classified as 'not improved' and the investigator may provide additional treatment. Follow up ends for eyes that receive additional treatment at this visit. However, if the investigator and participant elect to defer additional treatment (even if deferral criteria are not met), then follow up will continue until the study eye receives additional treatment for DME. * Eyes continuing in follow up have visits every 8 weeks (+1week) as long as there has been continued improvement in visual acuity (letter score improved \>5 ) or retinal thickness (central subfield thickness decreased by \>10%) compared with the visit 16 weeks earlier. The longest follow-up time will be 48 weeks. By providing information on the length of time during which clinically meaningful improvement occurs following focal photocoagulation, clinicians will be better able to determine
Interventions
- PROCEDURE Laser photocoagulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-06 |
What the finished NCT00442156 record still lists
NCT00442156 is an observational study that tracks outcomes without assigning an intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Laser photocoagulation is the first listed.
NCT00442156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00442156 about?
NCT00442156 is a clinical study titled "The Course of Response to Focal Photocoagulation for DME". The study objective is to determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME. The response will be evaluated separately in eyes with and without prior focal photocoagulation for DME. The pur...
What is the current status of trial NCT00442156?
This trial is currently completed. The enrollment target is 122 participants. The study started on 2007-01. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00442156?
The interventions under investigation include: Laser photocoagulation (PROCEDURE).
Who is sponsoring clinical trial NCT00442156?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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