Assessment of DOT Spectacles in Chinese Children Extension
NCT ID: NCT07008001
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
175 participants
INTERVENTIONAL
2025-08-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SightGlass Vision Test Arm Groups I (formerly test group)
Single vision, impact-resistant spectacle lenses
Novel spectacle lens design
Use of spectacle lenses may reduce the rate of progression of juvenile myopia
SightGlass Vision Test Arm Groups II (formerly control group)
Single vision, impact-resistant spectacle lenses
Novel spectacle lens design
Use of spectacle lenses may reduce the rate of progression of juvenile myopia
Interventions
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Novel spectacle lens design
Use of spectacle lenses may reduce the rate of progression of juvenile myopia
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
4. 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
8 Years
16 Years
ALL
Yes
Sponsors
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SightGlass Vision, Inc.
INDUSTRY
Responsible Party
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Locations
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Aier Eye Hospital
Changsha, , China
West China Hospital
Chengdu, , China
Zhongshan Ophthalmic Center
Guangzhou, , China
Fudan University EENT
Shanghai, , China
Tianjin Eye Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaoning Li
Role: primary
Longqian Liu
Role: primary
Xiao Yang
Role: primary
Peter Chen
Role: primary
Lihua Li
Role: primary
Other Identifiers
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CPRO-2201-002
Identifier Type: -
Identifier Source: org_study_id