NCT04380077

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

May 5, 2020

Last Update Submit

November 15, 2023

Conditions

Proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • postoperative vitreous hemorrhage rate

    incidence of postoperative vitreous hemorrhage between cohorts

    6 months

Secondary Outcomes (2)

  • unplanned vitrectomy rate

    6 months

  • visual acuity

    6 months

Study Arms (2)

sulfur hexafluoride gas

EXPERIMENTAL

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

Procedure: vitrectomy with sulfur hexafluoride gas

balanced salt solution

ACTIVE COMPARATOR

vitreous substitution with balanced salt solution during vitrectomy

Procedure: vitrectomy with balanced salt solution

Interventions

vitrectomy with sulfur hexafluoride gasPROCEDURE

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

sulfur hexafluoride gas
vitrectomy with balanced salt solutionPROCEDURE

vitreous substitution with balances salt solution during vitrectomy

balanced salt solution

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient has medically-managed type I or II diabetes mellitus.
  • The age of the patient is \> 18 years old,
  • Snellen best-corrected visual acuity is from 20/40 to hand motions at one foot in the subject's study eye
  • 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.
  • The vitreous hemorrhage is symptomatic and primarily responsible for the patient's reduced vision in the judgement of the examiner.
  • 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.

You may not qualify if:

  • The subject's study eye previously underwent anterior or posterior vitrectomy.
  • 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.).
  • 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.).
  • 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
  • Neovascular glaucoma with a high intraocular pressure ( \> 30 mm Hg) is discovered in the subject's study eye.
  • Medically uncontrolled systemic hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) is present.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Carlota Hospital

Montemorelos, Nuevo León, 67512, Mexico

Location

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ryan Rush, MD

    panhandle eye group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The operating surgeons did not participate in the preoperative or postoperative care of the patient, including the data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

May 15, 2020

Primary Completion

January 21, 2025

Study Completion

January 21, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)