Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Last updated: April 6, 2022
Sponsor: Panhandle Eye Group, LLP
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vitreous Hemorrhage

Diabetic Vitreous Hemorrhage

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT05318742
Protocol 0022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inthe research eye
  • Proliferative diabetic retinopathy with a vitreous hemorrhage is present in theresearch eye, and the vitreous hemorrhage is considered to be the primary cause forthe subject's reduced vision
  • The subject is panretinal photocoagulation-naïve
  • The vitreoretinal adhesion is Grade 0 or 1 according to the classification systempublished by Ahn et al in the research eye

Exclusion

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 fortwo or more lines of decreased visual acuity in the research eye (cataract, cornealscar, ectasia, etc.)
  • Optic nerve or retina disease unconnected to diabetes mellitus is thought to beresponsible 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 beresponsible 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 inthe research eye
  • Uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) ispresent

Study Design

Total Participants: 150
Study Start date:
February 15, 2022
Estimated Completion Date:
January 15, 2024

Study 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.

Connect with a study center

  • La Carlota Hospital

    Montemorelos, Nuevo Leon 67512
    Mexico

    Active - Recruiting

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