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Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

NCT04380077 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Proliferative Diabetic Retinopathy

Interventions

PROCEDURE

vitrectomy with sulfur hexafluoride gas

vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy

PROCEDURE

vitrectomy with balanced salt solution

vitreous substitution with balances salt solution during vitrectomy

Sponsors & Collaborators

  • Rush Eye Associates

    lead OTHER

Principal Investigators

  • Ryan Rush, MD · panhandle eye group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2025-01-21
Completion
2025-01-21

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380077 on ClinicalTrials.gov