CompletedNot Applicable

Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy

Mexico302 participantsStarted 2018-09-04

Plain-language summary

Subjects receiving 16% C3F8 gas tamponade during vitrectomy will have better visual acuity and similar postoperative complications to subjects who receive silicone oil tamponade during vitrectomy.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject age is 18-85 years.
✓. Subject consents to study participation and is capable of 6 months of follow-up.
✓. The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
✓. Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
✓. The subject is determined to need a PPV because of reduced BCSVA from 1) a TRD with or without RRD and/or vitreous hemorrhaging, or 2) extensive fibrous proliferation with or without vitreous hemorrhaging. When TRD is the reason for PPV, the TRD must be threatening (within one disc diameter) or involving the fovea. When fibrovascular proliferation is the reason for PPV, it must be extensive (\>3 clock hours) and threatening (within one disc diameter) or involving the fovea. The presence of subretinal fluid on B-scan ultrasonography, clinical exam, or OCT determines whether or not to classify the indication as TRD (subretinal fluid is present) or fibrous proliferation (no subretinal fluid present). Most subjects will have concurrent vitreous hemorrhaging, so it is critical that a B-scan ultrasound be performed to confirm a TRD or fibrous proliferation.
✓. Only one eye per patient is eligible for the study.

Exclusion criteria

✕. Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
✕. Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
✕. Subject has a significant corneal opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
✕. Subject has been documented to have had a macula-involving retinal detachment for greater than 6 months in the study eye.
✕. Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
✕. Subject has uncontrolled neovascular glaucoma (intraocular pressure \> 30 mmHg despite medical/surgical treatment) in the study eye.
✕. Subject has uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.

What they're measuring

BCVA

Timeframe: 6 months

Trial details

NCT IDNCT03660384

SponsorRush Eye Associates

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-04

View on ClinicalTrials.gov More Diabetic Retinopathy trials