BEYOND DISCO Lens for Myopia Progression Trial

Not Applicable

Recruiting

• Conditions: Myopia, Progressive
• Interventions: Other: spectacle lens; Other: single vision lens

• Registration Number: NCT06563700
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

This is a multi-center , prospective, randomised, longitudinal study to evaluate rate of myopia progression with ZEISS BD micro-structured spectacles compared to ZEISS Single-Vision spectacles. A total of 300 children will be recruited where 50 participants each are randomised to wear one of 5 test ZEISS BD spectacle lens designs or a single vision lens (control) for 12 months. At the end of 12 months, those randomised to single vision lenses will be transferred to one of the test lenses and all the groups continued for another 12 months. Myopia progression during the second year with test lenses will be compared to historical or published controls.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study Start: 2024-08-16
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

be accompanied by a parent or guardian who is able to read and comprehend Chinese/English and sign a record of informed consent/assent; at baseline, be within the age range of 7 to 13 years old inclusive; be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (D) and -5.00 dioptre (D); astigmatism ≤1.50D; anisometropia of not more than 1.50D; be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; have ocular findings deemed to be normal; vision correctable to at least 0.8 or better in each eye with spectacles.

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Exclusion Criteria

Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.

Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial.

History of eye trauma Amblyopia Strabismus History of use of myopia control interventions such as Orthokeratology, atropine or eye surgery 6 months prior to commencement of this trial.

Known allergy or intolerance to ingredients to cycloplegic eye-drops. Currently enrolled in another clinical trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	spectacle lens	single vision lens
Group A	single vision lens	single vision lens
Group B	spectacle lens	one of ZEISS BD spectacle lens designs 1 to 5
Group D	spectacle lens	one of ZEISS BD spectacle lens designs 1 to 5
Group C	spectacle lens	one of ZEISS BD spectacle lens designs 1 to 5
Group E	spectacle lens	one of ZEISS BD spectacle lens designs 1 to 5
Group F	spectacle lens	one of ZEISS BD spectacle lens designs 1 to 5

Primary Outcome Measures

Name	Time	Method
myopia progression	12 monthly	change in spherical equivalent from baseline for each of the groups of BD test lenses and the single vision control group

Secondary Outcome Measures

Name	Time	Method
axial elongation	12 monthly	change in axial length from baseline for each of the groups of BD test lenses and the single vision control group
Subjective responses and compliance	12 monthly	Subjective visual responses of wearing spectacles and compliance using questionair for each groups

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center; 🇨🇳 Shanghai, China