Status:
UNKNOWN
Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage
Lead Sponsor:
Panhandle Eye Group, LLP
Conditions:
Diabetic Vitreous Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication...
Detailed Description
Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endola...
Eligibility Criteria
Inclusion
- The subject has type I or II diabetes mellitus
- The age of the subject is \> 18 years old
- Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye
- Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision
- The subject is panretinal photocoagulation-naïve
- The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye
Exclusion
- The research eye had formerly undergone anterior or posterior vitrectomy.
- An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.)
- Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.)
- Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye
- Neovascular glaucoma with an elevated intraocular pressure (\> 30 mm Hg) is present in the research eye
- Uncontrolled systemic hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) is present
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05318742
Start Date
February 15 2022
End Date
January 15 2024
Last Update
April 8 2022
Active Locations (1)
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1
La Carlota Hospital
Montemorelos, Nuevo León, Mexico, 67512