Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

STATUS

Recruiting
participants needed

300
sponsor

Rush Eye Associates

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Updated on 19 February 2024

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diabetes

retinopathy

diabetic retinopathy

retinal detachment

detachment

vitrectomy

internal limiting membrane peeling

proliferative diabetic retinopathy

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

Description

Hypothesis

Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT and lower rates of DME, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.

Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.

Details

Condition	Diabetic Retinopathy, Diabetic Retinopathy, Diabetic Macular Edema, Diabetic Macular Edema
Age	18-85 years
Treatment	ILM Peeling, No ILM Peeling
Clinical Study Identifier	NCT04380064
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 indication of TRD (Grades 2 and 3).'
Exclusion Criteria
	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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Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy