Status:
UNKNOWN
Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics
Lead Sponsor:
Rush Eye Associates
Conditions:
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 per...
Detailed Description
Subjects enrolled into the study are randomized into one of the ensuing treatment cohorts: Group A patients undergo vitreous substitution with 20-30% sulfur hexafluoride (SF6) gas during PPV, whereas ...
Eligibility Criteria
Inclusion
- Inclusion:
- 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.
- Ahn J, Woo SJ, Chung H, et al. The effect of adjunctive intravitreal bevacizumab for preventing postvitrectomy hemorrhage in proliferative diabetic retinopathy. Ophthalmology. 2011; 118: 2218-2226.
- Exclusion:
- 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
- Neovascular glaucoma with a high intraocular pressure ( \> 30 mm Hg) is discovered in the subject's study eye.
- Medically uncontrolled systemic hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) is present.
Exclusion
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 21 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04380077
Start Date
May 15 2020
End Date
January 21 2025
Last Update
November 18 2023
Active Locations (1)
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1
La Carlota Hospital
Montemorelos, Nuevo León, Mexico, 67512