NCT03623074

Brief Summary

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

14 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jul 2018Dec 2026

Study Start

First participant enrolled

July 16, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

August 3, 2018

Last Update Submit

April 29, 2026

Conditions

Juvenile Myopia

Keywords

Myopia

Outcome Measures

Primary Outcomes (2)

  • Axial length

    Change in axial length from baseline

    36 Months

  • Spherical equivalent refraction

    Change in spherical equivalent refraction from baseline

    36 Months

Study Arms (3)

Test Arm 1

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design

Test Arm 2

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design

Test Arm 3

OTHER

Single vision, impact-resistant spectacle lenses

Device: Spectacle lenses

Interventions

Novel spectacle lens designDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Test Arm 1Test Arm 2
Spectacle lensesDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Test Arm 3

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
  • SER error between -0.75 and -4.50 D
  • SER power between the two eyes must be less than or equal to 1.50 D
  • Willingness to participate in the trial for 3 years without content lens wear

You may not qualify if:

  • Previous or current use of contact lenses
  • Previous or current use of bifocals, progressive addition spectacles lenses
  • Previous or current use of myopia control treatment
  • Astigmatism worse then -1.25 DC in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Visual Performance Center

Pensacola, Florida, 32503, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept

West Monroe, Louisiana, 71291, United States

Location

Advanced Eyecare, PC

Raytown, Missouri, 64133, United States

Location

SUNY School of Optometry

New York, New York, 10036, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Dept of Clinical Research, South Shore Eye Care, LLP

Wantagh, New York, 11793, United States

Location

Dunes Eye Consultants

Dakota Dunes, South Dakota, 57049, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

William J Bogus, OD, FAAO

Salt Lake City, Utah, 84106, United States

Location

Center for Ocular Research & Education, School of Optometry, University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

Location

Related Publications (1)

  • Rappon J, Chung C, Young G, Hunt C, Neitz J, Neitz M, Chalberg T. Control of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). Br J Ophthalmol. 2023 Nov;107(11):1709-1715. doi: 10.1136/bjo-2021-321005. Epub 2022 Sep 1.

    PMID: 36126105DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Joseph Rappon, OD, MS, FAAO

    SightGlass Vision, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and parents of participants will be masked. Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 9, 2018

Study Start

July 16, 2018

Primary Completion

May 15, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(13)CA(1)