Effects of Pneumatic Vitreolysis on Macular Hole

Part of paid clinical trials in Campbell, California.

Sponsor
Jaeb Center for Health Research
Study ID
NCT03677869
Status
Completed

Conditions

  • Full-thickness Macular Holes (MH)
  • Vitreomacular Traction (VMT)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraocular gas (C3F8) — DEVICE
    Intraocular gas (C3F8) injection

Study Details

Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.

Key Dates

First listed
Sep 19, 2018
Start date
Nov 14, 2018
Status verified
Sep 2022
Primary completion
Mar 16, 2020
Completion
Jul 22, 2020

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pneumatic vitreolysis (PVL)
    Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.

Primary Outcome Measure

Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy [ Time Frame: at 8 weeks ]

Locations (45)

FacilityCityStateZIPSite coordinators
Retinal Diagnostic CenterCampbellCalifornia95008-
Atlantis Eye CareHuntington BeachCalifornia92647-8693-
Northern California Retina Vitreous AssociatesMountain ViewCalifornia94040-4123-
East Bay Retina Consultants, Inc.OaklandCalifornia94609-3028-
Southern California Desert Retina Consultants, MCPalm DesertCalifornia92211-
National Ophthalmic Research InstituteFort MyersFlorida33912-
University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci CtrJacksonvilleFlorida32209-
Florida Retina ConsultantsLakelandFlorida33805-
Florida Retina InstituteOrlandoFlorida32806-1101-
Southeast Eye Institute, PA dba Eye Associates of PinellasPinellas ParkFlorida33782-4418-
Retina Associates of SarasotaSarasotaFlorida34233-1261-
Sarasota Retina InstituteSarasotaFlorida34239-
Southeast Retina Center, PCAugustaGeorgia30909-
Thomas Eye GroupSandy SpringsGeorgia30328-
Gailey Eye ClinicBloomingtonIllinois61704-2484-
University of Illinois at Chicago Medical CenterChicagoIllinois60612-
Illinois Retina Associates, SCOak ParkIllinois60304-
Carle Foundation HospitalUrbanaIllinois61801-2529-
Raj K. Maturi, MD, PCIndianapolisIndiana46290-
Wolfe Eye ClinicWest Des MoinesIowa50266-7705-
Mid-America Retina Consultants, P.A.Overland ParkKansas66211-
Paducah Retinal CenterPaducahKentucky42001-7502-
Eye Associates of Northeast Louisiana dba Haik Humble Eye CenterWest MonroeLouisiana71291-4452-
Elman Retina Group, BABaltimoreMaryland21237-
Valley Eye Physicians and SurgeonsAyerMassachusetts01432-1191-
Joslin Diabetes CenterBostonMassachusetts02215-
Vitreo-Retinal Associates, PCWorcesterMassachusetts01605-
Retina Specialists of MichiganGrand RapidsMichigan49546-3725-
Mayo Clinic Department of OphthalmologyRochesterMinnesota55905-
The Retina InstituteSt LouisMissouri63128-1729-
MaculaCareNew YorkNew York10021-
Retina-Vitreous Surgeons of Central New York, PCSyracuseNew York13224-
Western Carolina Clinical Research, LLCAshevilleNorth Carolina28803-
Charlotte Eye, Ear, Nose, and Throat Assoc., PACharlotteNorth Carolina28210-
Retina Associates of Cleveland, Inc.BeachwoodOhio44122-
Retina Vitreous CenterEdmondOklahoma73013-9791-
Oregon Retina, LLPEugeneOregon97401-7701-
Retina Northwest, PCPortlandOregon97221-
Southeastern Retina AssociatesChattanoogaTennessee37421-
Southeastern Retina Associates, PCKnoxvilleTennessee37909-
Austin Retina AssociatesAustinTexas78705-1169-
Retina Research CenterAustinTexas78705-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-
Retinal Consultants of San AntonioSan AntonioTexas78240-
Spokane Eye ClinicSpokaneWashington99204-

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