Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: a Randomized Clinical Trial

Hypothesis: Patients undergoing pars plana vitrectomy for the indication of diabetic vitreous hemorrhage will have a lower incidence of postoperative vitreous hemorrhaging during the 6-month trial period when vitreous substitution with 20-30% sulfur hexafluoride gas is utilized compared to vitreous substitution with balanced salt solution.

Study Overview

• Status: Active, not recruiting
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Procedure: vitrectomy with sulfur hexafluoride gas; Procedure: vitrectomy with balanced salt solution

Detailed Description

Subjects enrolled into the study are randomized into one of the ensuing treatment cohorts: Group A patients undergo vitreous substitution with 20-30% sulfur hexafluoride (SF6) gas during PPV, whereas Group B patients undergo vitreous substitution with balanced salt solution (BSS) during PPV. Simple randomization allocates patients into treatment groups during PPV. Once all relevant maneuvers are completed by the surgeon prior to vitreous substitution, a simulated coin toss program decides the vitreous substitute, and therefore which group the patient enters. Randomization intraoperatively mitigates against selection bias of utilized surgical maneuvers such as endodiathermy on the part of the surgeon and allows for subjects to not undergo randomization in cases where intraoperative retinal breaks occur that would preclude the subject from receiving vitreous substitution with BSS.

Subjects undergo data collection at 3 postoperative visits: 1) 15 +/- 5 days following PPV, 2) 40 +/- 10 days following PPV, and 3) 185 +/- 15 days following PPV. Study subjects are evaluated at non-study times at the judgment of the examiner.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Montemorelos, Nuevo Leon, Mexico, 67512
      • La Carlota Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion:

1. The patient has medically-managed type I or II diabetes mellitus.
2. The age of the patient is > 18 years old,
3. Snellen best-corrected visual acuity is from 20/40 to hand motions at one foot in the subject's study eye
4. Proliferative diabetic retinopathy with a clinically evident vitreous hemorrhage of duration of at least one month by subjective history is present in the subject's study eye.
5. The vitreous hemorrhage is symptomatic and primarily responsible for the patient's reduced vision in the judgement of the examiner.

6. Grade 0 or I vitreoretinal adhesion according to the classification system described by Ahn et al [@] in the study eye is clinically present.

   • Ahn J, Woo SJ, Chung H, et al. The effect of adjunctive intravitreal bevacizumab for preventing postvitrectomy hemorrhage in proliferative diabetic retinopathy. Ophthalmology. 2011; 118: 2218-2226.

Exclusion:

1. The subject's study eye previously underwent anterior or posterior vitrectomy.
2. A lens or cornea opacity is thought to be responsible for two or more lines of reduced visual acuity in the subject's study eye (cataract, corneal scar, ectasia, etc.).
3. Optic nerve or retina disease otherwise not related to diabetes mellitus is thought to be responsible for two or more lines of reduced visual acuity in the subject's study eye (optic neuritis, macular degeneration, glaucoma, epiretinal membrane, etc.).
4. A non-ocular cause (i.e. cerebrovascular accident) or amblyopia is thought to be responsible for two or more lines of reduced visual acuity in the subject's study eye
5. Neovascular glaucoma with a high intraocular pressure ( > 30 mm Hg) is discovered in the subject's study eye.
6. Medically uncontrolled systemic hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) is present.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sulfur hexafluoride gas; vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy	Procedure: vitrectomy with sulfur hexafluoride gas; vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy
Active Comparator: balanced salt solution; vitreous substitution with balanced salt solution during vitrectomy	Procedure: vitrectomy with balanced salt solution; vitreous substitution with balances salt solution during vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative vitreous hemorrhage rate	incidence of postoperative vitreous hemorrhage between cohorts	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
unplanned vitrectomy rate	unplanned vitrectomy for the indication of postoperative vitreous hemorrhage between cohorts	6 months
visual acuity	Snellen best-corrected visual acuity	6 months

Collaborators and Investigators

• Sponsor: Rush Eye Associates
• Investigators: Principal Investigator: Ryan Rush, MD, panhandle eye group

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Estimated): January 21, 2025
• Study Completion (Estimated): January 21, 2025

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Eye Hemorrhage; Retinal Diseases; Diabetic Retinopathy; Hemorrhage; Vitreous Hemorrhage
• Other Study ID Numbers: IRB0009239-Retina 5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No