Diabetic Retinopathy Clinical Trial
Official title:
A Prospective, Randomized Study Comparing 1000 Centistoke and 5000 Centistoke Silicone Oil Tamponade for Repair of Proliferative Vitreoretinopathy Retinal Detachments and Diabetic Tractional Retinal Detachments
Verified date | June 2013 |
Source | Mid Atlantic Retina |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.
Status | Completed |
Enrollment | 15 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Presence of rhegmatogenous retinal detachment or tractional retinal detachment due to grade C or worse proliferative vitreoretinopathy or proliferative diabetic retinopathy. - Judgment by the investigator that silicone oil tamponade is surgically indicated for appropriate repair of the complex retinal detachment. - Visual acuity of light perception or better. - Ability to provide written informed consent and comply with study assessments for the full duration of the study. Exclusion Criteria: - Inability to re-attach the retina at the time of surgery. - Prior trabeculectomy or tube shunt surgery. - Corneal opacity which limits visualization of the trabecular meshwork. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wills Eye Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Mid Atlantic Retina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retinal redetachment rate | Six months | No | |
Secondary | Best-corrected visual acuity | 6 and 12 months | No | |
Secondary | Silicone oil emulsification rate | Gonioscopy examination will be used at monthly postoperative visits to assess silicone oil emulsification in each patient. | Monthly | No |
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