Diabetic Vitreous Hemorrhage
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDURElaser
Endolaser photocoagulation during PPV
Sponsors
Panhandle Eye Group, LLP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Vitreous Hemorrhage | 6 months | The primary outcome measure of the trial was the incidence of postoperative VH during the 6-month trial period between treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative LogMAR visual acuity | 6 months | 6 month LogMAR visual acuity between groups |
Countries
Mexico
Contacts
Primary ContactChristi Rush
Backup ContactSloan Rush, MD
Outcome results
None listed