Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics (NCT04380077) | Clinical Trial Compass
UnknownNot Applicable
Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics
Mexico150 participantsStarted 2020-05-15
Plain-language summary
Hypothesis: Patients undergoing pars plana vitrectomy for the indication of diabetic vitreous hemorrhage will have a lower incidence of postoperative vitreous hemorrhaging during the 6-month trial period when vitreous substitution with 20-30% sulfur hexafluoride gas is utilized compared to vitreous substitution with balanced salt solution.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The patient has medically-managed type I or II diabetes mellitus.
✓. The age of the patient is \> 18 years old,
✓. Snellen best-corrected visual acuity is from 20/40 to hand motions at one foot in the subject's study eye
✓. Proliferative diabetic retinopathy with a clinically evident vitreous hemorrhage of duration of at least one month by subjective history is present in the subject's study eye.
✓. The vitreous hemorrhage is symptomatic and primarily responsible for the patient's reduced vision in the judgement of the examiner.
✓. Grade 0 or I vitreoretinal adhesion according to the classification system described by Ahn et al \[@\] in the study eye is clinically present.
Exclusion criteria
✕. The subject's study eye previously underwent anterior or posterior vitrectomy.
✕. A lens or cornea opacity is thought to be responsible for two or more lines of reduced visual acuity in the subject's study eye (cataract, corneal scar, ectasia, etc.).
✕. Optic nerve or retina disease otherwise not related to diabetes mellitus is thought to be responsible for two or more lines of reduced visual acuity in the subject's study eye (optic neuritis, macular degeneration, glaucoma, epiretinal membrane, etc.).
✕. A non-ocular cause (i.e. cerebrovascular accident) or amblyopia is thought to be responsible for two or more lines of reduced visual acuity in the subject's study eye