Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control (NCT06358755) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Combination Effect of Optical Defocus and Low Dose Atropine in Myopia Control
Hong Kong112 participantsStarted 2024-07-12
Plain-language summary
The purpose of the study is to investigate the combination effect of optical defocus and low dose atropine on myopia control in schoolchildren.
Who can participate
Age range7 Years – 12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age at enrollment: 7 to 12 years
* Ethnicity: Hong Kong Chinese
* Myopia: -0.75D (in spherical equivalent) or above in both eyes
* Astigmatism: -1.50D or less in both eyes
* Anisometropia: 1.50D or less (in spherical equivalent) between two eyes
* Best corrected monocular visual acuity (VA): 0.04 logMAR or better
* Ocular health: No abnormalities in both internal and external ocular health
* Systemic health: No abnormalities such as cardiac and respiratory diseases
* Binocular vision: No strabismus, diplopia, suppression and other binocular abnormalities
* Normal colour vision
* No previous refractive surgery or use of myopic control interventions, such as atropine, orthokeratology, and specialized spectacle lenses and contact lenses for myopic control
* Able to wear the prescribed spectacles
* No known allergy to atropine
Exclusion Criteria:
* Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
* Previous intraocular or corneal surgery
* Colour vision deficiencies
* Systemic disease that may affect vision, vision development (e.g. diabetes mellitus, hypertension, Down syndrome, etc.)
* Systemic disease that are contradictory to atropine (e.g. asthma, cardiac diseases, etc.)
* Previous gas permeable, soft bifocal, or orthokeratology contact lenses wear or bifocal / progressive addition lens spectacles wear or use of atropine or pirenzepine (longer than one month of usage)
* Previous o…
What they're measuring
1
Changes in cycloplegic refraction
Timeframe: Baseline, 6th month, 12th month and 18th month
2
Changes in axial length
Timeframe: Baseline, 6th month, 12th month and 18th month