NCT04380064

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.8 years

First QC Date

May 5, 2020

Last Update Submit

November 15, 2023

Conditions

Diabetic Retinopathy Visually Threatening

Outcome Measures

Primary Outcomes (1)

  • Postoperative ERM Development

    Postoperative Epiretinal Membrane Development

    6 months

Secondary Outcomes (1)

  • Visual Acuity

    6 months

Study Arms (2)

Study Group

EXPERIMENTAL

Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment

Procedure: ILM Peeling

Control Group

ACTIVE COMPARATOR

Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Procedure: No ILM Peeling

Interventions

ILM PeelingPROCEDURE

ILM peeling performed during primary PPV for PDR

Study Group
No ILM PeelingPROCEDURE

ILM peeling not performed during primary PPV for PDR

Control Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 TRD (Grades 2 and 3).

You may not qualify if:

  • 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 or cataract 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Carlota

Montemorelos, Nuevo León, Mexico

Location

Study Officials

  • Sloan Rush, MD

    panhandle eye group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

May 1, 2020

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)