Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Vitreous Hemorrhaging

  • STATUS
    Recruiting
  • End date
    Sep 4, 2022
  • participants needed
    250
  • sponsor
    Rush Eye Associates
Updated on 18 March 2021
diabetes
retinopathy
diabetic retinopathy
vitrectomy
proliferative diabetic retinopathy

Summary

Subjects undergoing ILM peeling during vitrectomy will have better visual acuity and lower rates of DME to control subjects

Description

Proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME) frequently occur together in patients with diabetic retinopathy In the landmark study Protocol S, about 30% of PDR subjects had DME at baseline and 53% of subjects receiving panretinal photocoagulation (PRP) underwent treatment for DME during the 2-year study interval. Vitreous hemorrhaging is one of the most common indications for pars plana vitrectomy (PPV) in patients with PDR. PDR patients undergoing PPV for the treatment of vitreous hemorrhaging often have coexisting DME, although it is often difficult to identify preoperatively because of the media opacification from the vitreous hemorrhage. Following successful PPV and vitreous hemorrhage resolution, PDR patients may then require prolonged DME treatment with repetitive intravitreal injections and/or focal lasers.

PPV with internal limiting membrane (ILM) peeling has been reported to reduce retinal edema and improve visual acuity in patients with DME. Although numerous studies report favorable outcomes in patients undergoing PPV with ILM peeling for the surgical indication of DME, there are presently not any studies evaluating ILM peeling in PDR patients undergoing PPV for the primary indication of vitreous hemorrhaging. Performing ILM peeling in conjunction with the usual techniques for addressing a vitreous hemorrhage (i.e. endolaser PRP, endodiathermy, etc.) during PPV may offer the benefits of better postoperative visual acuity and/or fewer postoperative treatments required to manage DME. In this randomized controlled trial, the authors evaluate the merits of ILM peeling in PDR patients undergoing PPV for the primary indication of vitreous hemorrhaging.

Details
Condition Macular Edema, age-related macular degeneration, Diabetic Retinopathy, Diabetic Macular Edema, Cystoid Macular Edema, Macular Degeneration
Treatment PPV/MP, PPV without MP
Clinical Study IdentifierNCT03660371
SponsorRush Eye Associates
Last Modified on18 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetic Retinopathy or Diabetic Macular Edema or Cystoid Macular Edema or age-related macular degeneration or Macular Degeneration or Macular Edema?
Do you have any of these conditions: Cystoid Macular Edema or Macular Degeneration or age-related macular degeneration or Diabetic Macular Edema or Macular Edema or Diabetic Retinopathy?
Do you have any of these conditions: Diabetic Macular Edema or Diabetic Retinopathy or Macular Edema or Cystoid Macular Edema or age-related macular degeneration or Macular Degeneration?
Subject age is 18-85 years
Subject consents to study participation and is capable of 6 months of follow-up
The subject has type I or II Diabetes Mellitus with active PDR in the study eye
Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye
The subject is determined to need a PPV for the indication of reduced BCSVA from vitreous hemorrhaging without substantial vitreoretinal (VR) adhesion (Grades 0 and 1)

Exclusion Criteria

Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye
Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye
Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye
Subject has a retinal detachment in the study eye
Subject has had a previous vitrectomy (anterior or PPV) in the study eye
Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye
Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen
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