Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Panhandle Eye Group, LLP

Status: Unknown

Conditions: Diabetic Vitreous Hemorrhage

Treatments: Procedure: laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05318742

Protocol 0022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Fewer Laser Spots

Active Comparator group

Description:

Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV

Treatment:

Procedure: laser

Higher Laser Spots

Active Comparator group

Description:

Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV

Treatment:

Procedure: laser