- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660384
Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
November 20, 2021 updated by: Sloan W. Rush, MD, Rush Eye Associates
Silicone Oil Versus Long-acting Gas Tamponade in Proliferative Diabetic Retinopathy Patients With High-grade Vitreoretinal Adhesion Undergoing Vitrectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Severe vision loss in patients with proliferative diabetic retinopathy (PDR) frequently results from complications related to neovascularization and fibrovascular proliferation.
Patients with PDR are typically considered candidates for pars plana vitrectomy (PPV) when non-clearing vitreous hemorrhaging, tractional retinal detachment (TRD) development with or without rhegmatogenous retinal detachment (RRD) or extensive fibrovascular proliferation occur.
Visual prognosis is often guarded in patients with PDR undergoing PPV with higher grades of vitreoretinal (VR) adhesion because of the high rate of both intra-operative and postoperative complications.
Releasing all significant traction caused by VR adhesion during PPV is critical for achieving long-term anatomic success and obtaining better visual outcomes in these patients with more advanced disease.
Failure to relieve VR adhesion often leads to persistent, recurrent or de novo TRD with or without RRD in the perioperative and postoperative period, which then results in one or more reoperations and ultimately a poor visual prognosis.
Maneuvers to remove VR adhesion during PPV are challenging and can result in posterior and/or peripheral retinal holes, which then may lead to postoperative proliferative vitreoretinopathy (PVR) and recurrent or de novo RRD.
Silicone oil and long-acting gas tamponade have been employed during PPV with reported success in cases with complex RRD and PVR.
And even though silicone oil and long-acting gas tamponade are currently in wide use for patients with PDR and high-grade VR adhesion undergoing PPV (especially when intra-operative breaks occur), little clinical data is available regarding which tamponading agent is best-suited for this patient population.
Previous studies have been retrospective in nature and are tarnished by selection bias when tamponading agents are compared (i.e.
cases with more severe grades of VR adhesion and intra-operative breaks typically are selected to receive silicone oil tamonade over gas).
Presently, there are not any randomized controlled trials reported on this topic.
In this randomized controlled trial, we compare silicone oil tamponade to 16% C3F8 gas tamponade in patients with PDR undergoing PPV for the management of TRD (with or without RRD) and/or extensive fibrovascular proliferation with or without vitreous hemorrhaging.
Study Type
Interventional
Enrollment (Actual)
302
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo Leon
-
Montemorelos, Nuevo Leon, Mexico
- Hospital La Carlota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SO
Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy
|
Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy
|
Experimental: C3F8
Subjects receive 16% C3F8 gas tamponade during vitrectomy
|
Subjects receive 16% C3F8 gas tamponade during vitrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BCVA
Time Frame: 6 months
|
best-corrected visual acuity
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sloan Rush, panhandle eye group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2018
Primary Completion (Actual)
March 4, 2020
Study Completion (Actual)
March 4, 2020
Study Registration Dates
First Submitted
September 4, 2018
First Submitted That Met QC Criteria
September 4, 2018
First Posted (Actual)
September 6, 2018
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 20, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Retina 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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