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ILM Peeling in PDR Patients Undergoing PPV for VH

NCT ID: NCT03660371

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-03-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Retinopathy Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PPV/MP

Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Group Type EXPERIMENTAL

PPV/MP

Intervention Type PROCEDURE

Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

PPV without MP

Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Group Type ACTIVE_COMPARATOR

PPV without MP

Intervention Type PROCEDURE

No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Interventions

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PPV/MP

Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Intervention Type PROCEDURE

PPV without MP

No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush Eye Associates

OTHER

Sponsor Role lead

Responsible Party

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Sloan W. Rush, MD

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sloan Rush

Role: STUDY_CHAIR

panhandle eye group

Locations

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Hospital La Carlota

Montemorelos, Nuevo León, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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Retina 2

Identifier Type: -

Identifier Source: org_study_id