NCT05893979

Brief Summary

To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses. To quantify axial length progression following cessation of use of specific spectacle lenses.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

8 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 Progress70%
Jun 2023Jul 2027

First Submitted

Initial submission to the registry

May 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

May 30, 2023

Last Update Submit

April 29, 2026

Conditions

MyopiaMyopia ProgressionJuvenile Myopia

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic Spherical Equivalent Refraction (cSER)

    Change in cSER

    12 months

Secondary Outcomes (2)

  • Cycloplegic Spherical Equivalent Refraction (cSER)

    6 months

  • Axial Length (AL)

    12 months

Study Arms (2)

Test Lens Group

ACTIVE COMPARATOR
Device: Spectacle Lenses

Control Lens Group

ACTIVE COMPARATOR
Device: Spectacle Lenses

Interventions

Spectacle LensesDEVICE

Standard Spectacle Lenses

Control Lens GroupTest Lens Group

Eligibility Criteria

Age9 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Previously a successfully completed participant in the CYPRESS Extension study;
  • 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 12 months 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 (8)

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

Advanced Eyecare PC

Raytown, Missouri, 64133, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Vision Optique

Houston, Texas, 77205, United States

Location

William J Bogus, OD, FAAO

Salt Lake City, Utah, 84106, United States

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

May 30, 2023

First Posted

June 8, 2023

Study Start

June 23, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(8)