Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2024-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Vitreous Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Fewer Laser Spots

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

Group Type ACTIVE_COMPARATOR

laser

Intervention Type PROCEDURE

Endolaser photocoagulation during PPV

Higher Laser Spots

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

Group Type ACTIVE_COMPARATOR

laser

Intervention Type PROCEDURE

Endolaser photocoagulation during PPV

Interventions

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laser

Endolaser photocoagulation during PPV

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No