Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Part of paid clinical trials in Oakland, California.

Sponsor
SightGlass Vision, Inc.
Study ID
NCT06034327
Status
Recruiting
Apply to this trial

Conditions

  • Juvenile Myopia
  • Myopia
  • Myopia Progression

Eligibility Criteria

Sex
ALL
Age
6 Years - 8 Years
Healthy Volunteers
Accepted

Interventions

  • Single vision, impact-resistant spectacle lenses; Test Arm — DEVICE
    Use of single vision, impact-resistant spectacle lenses may reduce the rate of progression of juvenile myopia
  • Single vision, impact-resistant spectacle lenses; Control Arm — DEVICE
    Single vision, impact-resistant spectacle lenses

Study Details

This is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. This is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.

Key Dates

Start date
Sep 18, 2023
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Arm 1
    Single vision, impact-resistant spectacle lenses
  • Other: Test Arm 2
    Single vision, impact-resistant spectacle lenses

Primary Outcome Measure

Spherical equivalent refraction [ Time Frame: 12 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Elsa Pao, ODOaklandCalifornia94607
Vanessa Chen
510-238-9797
Elsa Pao, OD (PRINCIPAL_INVESTIGATOR)
Scripps Poway EyecareSan DiegoCalifornia92131
Leslie Shan, OD
858-530-2800
Keith Wan, OD (PRINCIPAL_INVESTIGATOR)
Pacific Rims OptometrySan FranciscoCalifornia94127
Aileen Guzman
415-655-3937
Selena Chan, OD (PRINCIPAL_INVESTIGATOR)
Paje OptometricSanta AnaCalifornia92704
Daisy Magdaleno
714-557-9492
Vanessa Grichine, OD (PRINCIPAL_INVESTIGATOR)
Omega Vision CenterLongwoodFlorida32779
Renee Warren
407-869-4733
Christopher Pearson, OD (PRINCIPAL_INVESTIGATOR)
Marietta Eye ClinicMariettaGeorgia30060
Doreatha Kennerly
678-803-2600
Monica Bratton, MD (PRINCIPAL_INVESTIGATOR)
Ilinois College of OptometryChicagoIllinois60616
Jessica Martinez
312-949-7000
Yi Pang, OD (PRINCIPAL_INVESTIGATOR)
Kannarr Eye CarePittsburgKansas66762
Megan Compton, RN
620-235-1737
Shane Kannarr, OD (PRINCIPAL_INVESTIGATOR)
New England College of OptometryBostonMassachusetts02115
Lilly Cheam
617-266-2030
Katherine Green, OD (PRINCIPAL_INVESTIGATOR)
Advanced Eyecare PCRaytownMissouri64133
Tamara Urias
816-353-1872
Richard Wilson, OD (PRINCIPAL_INVESTIGATOR)
Athens Eye CareAthensOhio45701
Jen Brite
740-594-2271
Shane Foster, OD
Shane Foster, OD (PRINCIPAL_INVESTIGATOR)
Procare Vision Centers, Inc.GranvilleOhio43023
Katherine Bickle, OD
Katherine Bickle, OD (PRINCIPAL_INVESTIGATOR)
Texas State Optical - DowlenBeaumontTexas77706
Bobbie Hampton
409-899-9999
Samir Patel, OD (PRINCIPAL_INVESTIGATOR)
Bellaire Family Eye CareBellaireTexas77401
Ashley Tucker, OD
Ashley Tucker, OD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oakland, CA

By research site
Elsa Pao, OD· Oakland, CAScripps Poway Eyecare· San Diego, CAPacific Rims Optometry· San Francisco, CAPaje Optometric· Santa Ana, CAOmega Vision Center· Longwood, FLMarietta Eye Clinic· Marietta, GA

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