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ILM Peeling in PDR Patients Undergoing PPV for VH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660371
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Rush Eye Associates

Study Description
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Brief Summary:
Subjects undergoing ILM peeling during vitrectomy will have better visual acuity and lower rates of DME to control subjects

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Macular Edema Procedure: PPV/MP Procedure: PPV without MP Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Vitreous Hemorrhaging
Actual Study Start Date : September 4, 2018
Actual Primary Completion Date : March 4, 2020
Actual Study Completion Date : March 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PPV/MP
Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
 Procedure: PPV/MP
Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
Active Comparator: PPV without MP
Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
 Procedure: PPV without MP
No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging


Outcome Measures
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Primary Outcome Measures :
  1. BCVA [ Time Frame: 6 months ]
    best-corrected visual acuity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject age is 18-85 years.
  2. Subject consents to study participation and is capable of 6 months of follow-up.
  3. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
  4. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
  5. 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:

  1. 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.
  2. 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.
  3. 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.
  4. Subject has a retinal detachment in the study eye.
  5. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
  6. Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
  7. Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660371


Locations
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Mexico
Hospital La Carlota
Montemorelos, Nuevo Leon, Mexico
Sponsors and Collaborators
Rush Eye Associates
Investigators
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Study Chair: Sloan Rush panhandle eye group
More Information
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Responsible Party: Sloan W. Rush, MD, Physician, Rush Eye Associates
ClinicalTrials.gov Identifier: NCT03660371    
Other Study ID Numbers: Retina 2
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
 Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases