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NCT Number: NCT07008001

Assessment of DOT Spectacles in Chinese Children Extension

This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.

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Key information

Conditions

Juvenile Myopia Eye Diseases Myopia Refractive Errors

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aier Eye Hospital, Changsha, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously a successfully completed participant in the CATHAY study (NCT05562622)
  • 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 12 months without contact lens wear or any other myopia management intervention
  • 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 or cyclopentolate

Treatment and study plan

Novel spectacle lens design

Device

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

Primary outcomes

  1. Axial length Group I

    Time frame: 12 months

    Change in axial length from baseline to 36 months

  2. Axial length Group II

    Time frame: 12 months

    Change in axial length from baseline to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer S Hill, BS

CONTACT

[email protected]

678-361-4877

Vanessa Tasso, MA, MBA

CONTACT

[email protected]

949-751-7039

Sponsors and collaborators

Lead sponsor

SightGlass Vision, Inc.

Industry

Registry information

Official study title

Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension

Acronym: CATHAY Ext

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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