Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

Not Applicable

Active, not recruiting

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Procedure: vitrectomy with sulfur hexafluoride gas; Procedure: vitrectomy with balanced salt solution

• Registration Number: NCT04380077
• Lead Sponsor: Rush Eye Associates

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Study Start: 2020-05-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sulfur hexafluoride gas	vitrectomy with sulfur hexafluoride gas	vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy
balanced salt solution	vitrectomy with balanced salt solution	vitreous substitution with balanced salt solution during vitrectomy

Primary Outcome Measures

Name	Time	Method
postoperative vitreous hemorrhage rate	6 months	incidence of postoperative vitreous hemorrhage between cohorts

Secondary Outcome Measures

Name	Time	Method
visual acuity	6 months	Snellen best-corrected visual acuity
unplanned vitrectomy rate	6 months	unplanned vitrectomy for the indication of postoperative vitreous hemorrhage between cohorts

Trial Locations

Locations (1)

La Carlota Hospital; 🇲🇽 Montemorelos, Nuevo Leon, Mexico