Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Study Overview
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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.

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.

Official Title
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Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount

Conditions
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Diabetic Vitreous Hemorrhage

Intervention / Treatment
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* Procedure: laser


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fewer Laser Spots<br>Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV | Procedure: laser<br>* Endolaser photocoagulation during PPV<br>|
| Active Comparator: Higher Laser Spots<br>Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV | Procedure: laser<br>* Endolaser photocoagulation during PPV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Vitreous Hemorrhage | The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative LogMAR visual acuity | 6 month LogMAR visual acuity between groups | 6 months |