NCT04947735

Brief Summary

This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles 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
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
active not recruiting

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

Study Progress88%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

June 18, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

July 19, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

June 18, 2021

Last Update Submit

April 29, 2026

Conditions

Juvenile MyopiaMyopia

Outcome Measures

Primary Outcomes (2)

  • Axial length

    Test vs. control axial length change from baseline

    72 months

  • Spherical equivalent refraction (SER)

    Test vs. control spherical equivalent refraction (SER) change from baseline

    72 months

Secondary Outcomes (2)

  • Axial length

    42 months

  • SER

    60 months

Study Arms (2)

CYPRESS Extension Test Arm

EXPERIMENTAL

Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm

Device: Novel spectacle lens design

CYPRESS Extension Control Arm

PLACEBO COMPARATOR

Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm

Device: Spectacle lenses

Interventions

Novel spectacle lens designDEVICE

Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia

CYPRESS Extension Test Arm
Spectacle lensesDEVICE

Single vision, impact resistant spectacle lenses

CYPRESS Extension Control Arm

Eligibility Criteria

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

You may qualify if:

  • Previously a successfully completed participant in the CYPRESS study (NCT03623074) and having not exited this study for more than 30 days;
  • Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
  • Willingness to participate in the trial for up to 3 years without contact lens wear;
  • The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

You may not qualify if:

  • Known allergy to proparacaine, tetracaine, or tropicamide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Golden Optometric Group

Whittier, California, 90606, United States

Location

Omega Vision Center, PA

Longwood, Florida, 32779, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Haik Humble

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

Dunes Eye Consultants

Dakota Dunes, South Dakota, 57049, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Dr. Bridgitte Shen Lee (PI)

Houston, Texas, 77205, United States

Location

William J Bogus, OD, FAAO

Salt Lake City, Utah, 84106, United States

Location

Centre for Ocular Research and Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 1, 2021

Study Start

July 19, 2021

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(11)CA(1)