Early Vitrectomy vs. Conventional Management in Severe Diabetic Retinopathy
Data Collection
Cardiovascular Diseases+12
+ Diabetes Mellitus
+ Diabetic Angiopathies
Treatment Study
Summary
Study start date: October 1, 1976
Actual date on which the first participant was enrolled.This study is about exploring the benefits and risks of a procedure called vitrectomy for people with diabetic retinopathy, a condition that affects the eyes. Diabetic retinopathy can cause bleeding in the eye and lead to vision loss. The study aims to find out if performing vitrectomy early can improve vision or if it might lead to more serious complications than the usual care. The study is important because it could help doctors understand the best way to treat this condition and potentially improve care for people with diabetic retinopathy. The study involves two parts. In the first part, people who have severe vision loss due to bleeding in the eye are randomly assigned to either get an early vitrectomy or follow the usual care. If the bleeding doesn't clear up after a year or if the retina starts to detach, then a vitrectomy is performed. In the second part, people with severe fibrovascular proliferations but still have useful vision are also randomly assigned to either get an early vitrectomy or follow the usual care. The usual care includes a treatment called photocoagulation, and a vitrectomy is performed if there's severe bleeding that doesn't clear up within 6 months or if the retina starts to detach. All participants are checked every 6 months for 2 years and then once a year to see how their vision changes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Men and women eligible for the vitreous hemorrhage group had at least one eye with recent severe vitreous hemorrhage (within 5 months) and visual acuity of 5/200 or less. Patients eligible for the "very severe proliferative retinopathy with useful vision" group had extensive active fibrovascular proliferations and visual acuity of 10/200 or better.