Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Not Applicable

• Conditions: Diabetic Vitreous Hemorrhage
• Interventions: Procedure: laser

• Registration Number: NCT05318742
• Lead Sponsor: Panhandle Eye Group, LLP

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-01-01
• Study Start: 2022-02-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher Laser Spots	laser	Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV
Fewer Laser Spots	laser	Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative LogMAR visual acuity	6 months	6 month LogMAR visual acuity between groups

Trial Locations

Locations (1)

La Carlota Hospital; 🇲🇽 Montemorelos, Nuevo Leon, Mexico