Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

STATUS

Recruiting
participants needed

300
sponsor

Rush Eye Associates

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Updated on 19 February 2024

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diabetes

vitrectomy

vitreous hemorrhage

Summary

Subjects undergo vitreous substitution with either SF6 gas or fluid during vitrectomy.

Description

Hypothesis: Subjects undergoing vitreous substitution with 30% SF6 gas during vitrectomy will have fewer postoperative vitreous hemorrhages compared to control subjects

Randomization: Subjects will be randomized according to a coin toss during PPV: heads undergo 30% SF6 gas tamponade, tails undergo vitreous substitution with fluid

Details

Condition	Proliferative Diabetic Retinopathy
Age	18years - 85years
Treatment	SF6, Fluid
Clinical Study Identifier	NCT04380077
Sponsor	Rush Eye Associates
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	b'Subject age is 18-85 years.'
	b'Subject consents to study participation and is capable of 6 months of follow-up.'
	b'The subject has type I or II Diabetes Mellitus with active PDR in the study eye.'
	b'Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from'
	b'20/40 to hand motions in the study eye.'
	b'The subject is determined to need a PPV for the primary indication of VH secondary to'
	b'PDR.'
Exclusion Criteria
	b'Subject has significant vitreoretinal adhesion (Grades 2 or 3) (i.e. extensive fibrous'
	b'proliferation or tractional retinal detachment).'
	b'Subject is known to have a significant retinal/optic nerve disease otherwise unrelated'
	b'to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or'
	b'more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma,'
	b'amblyopia, etc.) in the study eye.'
	b'Subject is known to have macular ischemia, which in the opinion of the examiner, is'
	b'responsible for two or more lines of reduced BCSVA in the study eye.'
	b'Subject has a significant corneal or cataract opacity, which in the opinion of the'
	b'examiner, is responsible for two or more lines of reduced BCSVA (corneal scar,'
	b'ectasia, etc.) in the study eye.'
	b'Subject has had a previous vitrectomy (anterior or PPV) in the study eye.'
	b'Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite'
	b'medical/surgical treatment) in the study eye.'
	b'Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg)'
	b'despite adherence to a multiple anti-hypertensive medication regimen.'

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Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics