Clinical trial NCT05318742: Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage
Official title: Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial Comparing Treatment Amount
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Vitreous Hemorrhage
Lead sponsor: Panhandle Eye Group, LLP
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Vitreous Hemorrhage
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative LogMAR visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Montemorelos
country: Mexico
facility: La Carlota Hospital
state: Nuevo Leon
Study officials:
affiliation: panhandle eye group
name: Sloan Rush, MD
role: STUDY_DIRECTOR
References: