Last updated: April 6, 2022
Sponsor: Panhandle Eye Group, LLP
Overall Status: Active - Recruiting
Phase
N/A
Condition
Vitreous Hemorrhage
Diabetic Vitreous Hemorrhage
Diabetic Retinopathy
Treatment
N/AClinical Study ID
NCT05318742
Protocol 0022
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 inthe research eye
- Proliferative diabetic retinopathy with a vitreous hemorrhage is present in theresearch eye, and the vitreous hemorrhage is considered to be the primary cause forthe subject's reduced vision
- The subject is panretinal photocoagulation-naïve
- The vitreoretinal adhesion is Grade 0 or 1 according to the classification systempublished by Ahn et al in the research eye
Exclusion
Exclusion Criteria:
- The research eye had formerly undergone anterior or posterior vitrectomy.
- An opacity of the anterior segment (cornea or lens) is thought to be responsible fortwo or more lines of decreased visual acuity in the research eye (cataract, cornealscar, ectasia, etc.)
- Optic nerve or retina disease unconnected to diabetes mellitus is thought to beresponsible 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 beresponsible 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 inthe research eye
- Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) ispresent
Study Design
Total Participants: 150
Study Start date:
February 15, 2022
Estimated Completion Date:
January 15, 2024
Study Description
Connect with a study center
La Carlota Hospital
Montemorelos, Nuevo Leon 67512
MexicoActive - Recruiting
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