Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

Diabetic Vitreous Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318742
• Other study ID #: Protocol 0022
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: April 2022
• Source: Panhandle Eye Group, LLP
• Contact: Christi Rush
• Phone: 8066740200
• Email: christirush123[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Vitreous Hemorrhage
• Hemorrhage
• Vitreous Hemorrhage

Intervention

Procedure:
• laser
Endolaser photocoagulation during PPV

Locations

Country	Name	City	State
Mexico	La Carlota Hospital	Montemorelos	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Panhandle Eye Group, LLP

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative LogMAR visual acuity	6 month LogMAR visual acuity between groups	6 months