Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount

In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication of VH.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Vitreous Hemorrhage
• Intervention / Treatment: Procedure: laser

Detailed Description

Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV. Simple randomization will allocate subjects into treatment groups during PPV. Once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser PRP, a coin toss simulation program will randomize subjects into treatment groups.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christi Rush; Phone Number: 8066740200; Email: christirush123@gmail.com
• Study Contact Backup: Name: Sloan Rush, MD; Phone Number: 8066740200; Email: sloan.rush@paneye.com

Study Locations

• Mexico
  • Nuevo Leon
    • Montemorelos, Nuevo Leon, Mexico, 67512
      • Recruiting
      • La Carlota Hospital
      • Contact: Sloan Rush, MD; Phone Number: 8066740200; Email: sloan.rush@paneye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject has type I or II diabetes mellitus
• The age of the subject is > 18 years old
• Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye
• Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision
• The subject is panretinal photocoagulation-naïve
• The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye

Exclusion Criteria:

• The research eye had formerly undergone anterior or posterior vitrectomy.
• An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.)
• Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.)
• Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye
• Neovascular glaucoma with an elevated intraocular pressure (> 30 mm Hg) is present in the research eye
• Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) is present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fewer Laser Spots; Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV	Procedure: laser; Endolaser photocoagulation during PPV
ACTIVE_COMPARATOR: Higher Laser Spots; Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV	Procedure: laser; Endolaser photocoagulation during PPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Vitreous Hemorrhage	The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative LogMAR visual acuity	6 month LogMAR visual acuity between groups	6 months

Collaborators and Investigators

• Sponsor: Panhandle Eye Group, LLP
• Investigators: Study Director: Sloan Rush, MD, panhandle eye group

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2022
• Primary Completion (ANTICIPATED): January 15, 2024
• Study Completion (ANTICIPATED): January 15, 2024

Study Registration Dates

• First Submitted: January 1, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (ACTUAL): April 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Eye Hemorrhage; Hemorrhage; Vitreous Hemorrhage
• Other Study ID Numbers: Protocol 0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No