Assessment of DOT Spectacles in Chinese Children | NCT05562622

Studies
Assessment of DOT Spectacles in Chinese Children

NCT05562622

Sponsor

SightGlass Vision, Inc.

Status

Active, not recruiting

Last Update Posted

May 5, 2026Actual

Enrollment

195Actual

Phase

Not Applicable

Conditions

Juvenile Myopia
Myopia

Interventions

Novel spectacle lens design
Spectacle lenses

Countries

China

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

Feb 5, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Sep 28, 2022

First Submission Date that Met QC Criteria

Sep 28, 2022

First Posted Date

Oct 3, 2022Actual

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

This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.

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

195Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SightGlass Vision Test Arm 1	Experimental	Single vision, impact-resistant spectacle lenses	Device: Novel spectacle lens design
Test Arm 2	Other	Single vision, impact-resistant spectacle lenses	Device: Spectacle lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novel spectacle lens design	Device	Use of lenses may reduce the rate of progression of juvenile myopia	SightGlass Vision Test Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Axial length	Change in axial length from baseline	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children 6-13 years of age
SER error between -0.75D and -5.00D
Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear

Exclusion Criteria:

Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
Anisometropia (SER manifest refraction) greater than 1.00 D

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

13 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
Aier Eye Hospital		Changsha			China
West China Hospital

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases