Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy
Mexico200 participantsStarted 2020-05-01
Plain-language summary
Subject/Participant Groups:
Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subject age is 18-85 years.
✓. Subject consents to study participation and is capable of 6 months of follow-up.
✓. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
✓. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
✓. The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).
Exclusion criteria
✕. Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
✕. Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
✕. Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
✕. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
✕. Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.