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 range

18 Years – 85 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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