NCT03660384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

September 4, 2018

Last Update Submit

November 20, 2021

Conditions

Diabetic RetinopathyRetinal Detachment

Outcome Measures

Primary Outcomes (1)

  • BCVA

    best-corrected visual acuity

    6 months

Study Arms (2)

SO

EXPERIMENTAL

Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy

Procedure: PPV/SO

C3F8

EXPERIMENTAL

Subjects receive 16% C3F8 gas tamponade during vitrectomy

Procedure: PPV/C3F8

Interventions

PPV/SOPROCEDURE

Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy

SO
PPV/C3F8PROCEDURE

Subjects receive 16% C3F8 gas tamponade during vitrectomy

C3F8

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Carlota

Montemorelos, Nuevo León, Mexico

Location

MeSH Terms

Conditions

Diabetic RetinopathyRetinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Sloan Rush

    panhandle eye group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

September 4, 2018

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)