Gas Tamponade for Prevention of Postoperative Vitreous Hemorrhage in Diabetics

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04380077
• Other study ID #: IRB0009239-Retina 5
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: January 21, 2025

Study information

• Verified date: November 2023
• Source: Rush Eye Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 21, 2025
• Est. primary completion date: January 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Vitreous Hemorrhage

Intervention

Procedure:
• vitrectomy with sulfur hexafluoride gas
vitreous substitution with 20-30% sulfur hexafluoride gas during vitrectomy
• vitrectomy with balanced salt solution
vitreous substitution with balances salt solution during vitrectomy

Locations

Country	Name	City	State
Mexico	La Carlota Hospital	Montemorelos	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Rush Eye Associates

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative vitreous hemorrhage rate	incidence of postoperative vitreous hemorrhage between cohorts	6 months
Secondary	unplanned vitrectomy rate	unplanned vitrectomy for the indication of postoperative vitreous hemorrhage between cohorts	6 months
Secondary	visual acuity	Snellen best-corrected visual acuity	6 months