Back to resultsSilicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
Primary Purpose
Diabetic Retinopathy, Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
PPV/SO
PPV/C3F8
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy
Eligibility Criteria
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.
Sites / Locations
- Hospital La Carlota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SO
C3F8
Arm Description
Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy
Subjects receive 16% C3F8 gas tamponade during vitrectomy
Outcomes
Primary Outcome Measures
BCVA
best-corrected visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT03660384
First Posted
September 4, 2018
Last Updated
November 20, 2021
Sponsor
Rush Eye Associates
1. Study Identification
Unique Protocol Identification Number
NCT03660384
Brief Title
Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
Official Title
Silicone Oil Versus Long-acting Gas Tamponade in Proliferative Diabetic Retinopathy Patients With High-grade Vitreoretinal Adhesion Undergoing Vitrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush Eye Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Retinal Detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SO
Arm Type
Experimental
Arm Description
Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy
Arm Title
C3F8
Arm Type
Experimental
Arm Description
Subjects receive 16% C3F8 gas tamponade during vitrectomy
Intervention Type
Procedure
Intervention Name(s)
PPV/SO
Intervention Description
Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy
Intervention Type
Procedure
Intervention Name(s)
PPV/C3F8
Intervention Description
Subjects receive 16% C3F8 gas tamponade during vitrectomy
Primary Outcome Measure Information:
Title
BCVA
Description
best-corrected visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sloan Rush
Organizational Affiliation
panhandle eye group
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital La Carlota
City
Montemorelos
State/Province
Nuevo Leon
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
We'll reach out to this number within 24 hrs