Myopia Control Spectacle Lens Cessation Study | NCT05893979

Studies
Myopia Control Spectacle Lens Cessation Study

NCT05893979

Sponsor

SightGlass Vision, Inc.

Status

Active, not recruiting

Last Update Posted

May 5, 2026Actual

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Myopia
Myopia Progression
Juvenile Myopia

Interventions

Spectacle Lenses

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

May 30, 2023

First Submission Date that Met QC Criteria

May 30, 2023

First Posted Date

Jun 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Lens Group	Active Comparator		Device: Spectacle Lenses
Control Lens Group	Active Comparator		Device: Spectacle Lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spectacle Lenses	Device	Standard Spectacle Lenses	Control Lens Group Test Lens Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cycloplegic Spherical Equivalent Refraction (cSER)	Change in cSER	12 months

Secondary Outcomes

Measure	Description	Time Frame
Cycloplegic Spherical Equivalent Refraction (cSER)	Change in cSER	6 months
Axial Length (AL)	Change in AL	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Known allergy to proparacaine, tetracaine, or tropicamide.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Golden Optometric Group		Whittier	California	90606	United States
Omega Vision Center PA

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases