Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

NCT05318742 | Unknown DMC

• 1 other identifier: Protocol 0022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Vitreous Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative LogMAR visual acuity

  6 months

Study Arms (2)

Fewer Laser Spots

ACTIVE COMPARATOR

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

Procedure: laser

Higher Laser Spots

ACTIVE COMPARATOR

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

Procedure: laser

Interventions

laser PROCEDURE

Endolaser photocoagulation during PPV

Fewer Laser Spots; Higher Laser Spots

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panhandle Eye Group, LLP: lead

Study Sites (1)

La Carlota Hospital

Montemorelos, Nuevo León, 67512, Mexico

RECRUITING

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Sloan Rush, MD

  panhandle eye group

  STUDY DIRECTOR

Central Study Contacts

Christi Rush

CONTACT

8066740200; christirush123@gmail.com

Sloan Rush, MD

CONTACT

8066740200; sloan.rush@paneye.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2022
• First Posted: April 8, 2022
• Study Start: February 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)