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Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Active

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

vitrectomy with sulfur hexafluoride gas

vitrectomy with balanced salt solution

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

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.

Exclusion:

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.

Sites / Locations

La Carlota Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sulfur hexafluoride gas

balanced salt solution

Arm Description

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

vitreous substitution with balanced salt solution during vitrectomy

Outcomes

Primary Outcome Measures

postoperative vitreous hemorrhage rate

incidence of postoperative vitreous hemorrhage between cohorts

Secondary Outcome Measures

unplanned vitrectomy rate

unplanned vitrectomy for the indication of postoperative vitreous hemorrhage between cohorts

visual acuity

Snellen best-corrected visual acuity

Full Information

NCT ID

NCT04380077

First Posted

May 5, 2020

Last Updated

October 24, 2022

Sponsor

Rush Eye Associates

1. Study Identification

Unique Protocol Identification Number

NCT04380077

Brief Title

Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 15, 2020 (Actual)

Primary Completion Date

January 21, 2025 (Anticipated)

Study Completion Date

January 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush Eye Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Masking Description

The operating surgeons did not participate in the preoperative or postoperative care of the patient, including the data collection.

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sulfur hexafluoride gas

Arm Type

Experimental

Arm Description

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

Arm Title

balanced salt solution

Arm Type

Active Comparator

Arm Description

vitreous substitution with balanced salt solution during vitrectomy

Intervention Type

Procedure

Intervention Name(s)

vitrectomy with sulfur hexafluoride gas

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

vitrectomy with balanced salt solution

Intervention Description

vitreous substitution with balances salt solution during vitrectomy

Primary Outcome Measure Information:

Title

postoperative vitreous hemorrhage rate

Description

incidence of postoperative vitreous hemorrhage between cohorts

Time Frame

6 months

Secondary Outcome Measure Information:

Title

unplanned vitrectomy rate

Description

unplanned vitrectomy for the indication of postoperative vitreous hemorrhage between cohorts

Time Frame

6 months

Title

visual acuity

Description

Snellen best-corrected visual acuity

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: 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. Exclusion: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Rush, MD

Organizational Affiliation

panhandle eye group

Official's Role

Principal Investigator

Facility Information:

Facility Name

La Carlota Hospital

City

Montemorelos

State/Province

Nuevo Leon

ZIP/Postal Code

67512

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

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