Completed

Silicone Oil vs Gas Tamponade in Retinal Detachment Treatment

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What is being tested

Data Collection

Who is being recruted

Eye Diseases+1

+ Retinal Detachment

+ Retinal Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 1985
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1985

Actual date on which the first participant was enrolled.

Retinal detachment complicated by PVR can be challenging to treat. While some cases respond well to pars plana vitrectomy and temporary support from intraocular gas, others may redetach. Preliminary findings suggest that prolonged support with liquid silicone can improve success rates, but there may be complications such as glaucoma and keratopathy. This study aims to compare the benefits of silicone oil versus gas as support methods in this procedure. It focuses on two groups: those who haven't had a prior vitrectomy (Group 1) and those who have (Group 2). The goal is to find a more effective and safer treatment approach for this condition. During the study, all participants undergo vitrectomy and are randomly assigned to receive either silicone oil or gas. The surgical procedure is standardized to relieve retinal traction, and the eye's response is assessed using an intraocular air support. The assignment to silicone oil or gas only happens after the surgical procedure to avoid any bias. Participants are then examined multiple times over a 36-month period, with repeat surgery allowed if necessary. The study's end points are visual acuity of 5/200 or greater and macular reattachment for 6 months following the final surgery. The success rates and complication rates of the two support methods are then compared.

Official TitleThe Silicone Study
Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesRetinal DetachmentRetinal DiseasesVitreoretinopathy, Proliferative

Criteria

Eligibility criteria included but were not limited to PVR of Grade C-3 or greater according to the Retina Society Classification and visual acuity of light perception or better.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers