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Active, Not Recruiting

NCT Number: NCT05562622

Assessment of DOT Spectacles in Chinese Children

This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial 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 myopia in children of Chinese origin.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Juvenile Myopia Eye Diseases Myopia Refractive Errors

Age range

6 year–13 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

  • 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

Treatment and study plan

Novel spectacle lens design

Device

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

Spectacle lenses

Device

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

Primary outcomes

  1. Axial length

    Time frame: 12 months

    Change in axial length from baseline

Secondary outcomes

  1. Axial length

    Time frame: 24 months

    Change in axial length from baseline

  2. Axial length

    Time frame: 36 months

    Change in axial length from baseline

Sponsors and collaborators

Lead sponsor

SightGlass Vision, Inc.

Industry

Registry information

Official study title

Clinical Assessment of DOT Spectacle Lenses in Chinese Children

Acronym: CATHAY

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Jul 13, 2026

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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