Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

  • STATUS
    Recruiting
  • End date
    Jan 15, 2024
  • participants needed
    150
  • sponsor
    Panhandle Eye Group, LLP
Updated on 27 April 2022

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.

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.

Details
Condition Diabetic Vitreous Hemorrhage
Treatment Laser
Clinical Study IdentifierNCT05318742
SponsorPanhandle Eye Group, LLP
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

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
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