Status:
UNKNOWN
Eye Length Signal With Myopia Control
Lead Sponsor:
Brien Holden Vision Institute
Conditions:
Myopia
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief Summary
Myopia, considered as a global epidemic, is rapidly rising in prevalence especially in east Asian countries. Younger ages are associated with greater annual progression and thus early onset myopia is ...
Detailed Description
To date, the strategies used to control or slow the progression of myopia are optical and pharmaceutical methods. Among spectacles, bifocal spectacles with and without prism, progressive addition lens...
Eligibility Criteria
Inclusion
- be aged between 7 to 14 completed years (7 and 14 years inclusive), irrespective of gender.
- have cycloplegic autorefraction spherical component -0.50 D to - 4.50D, cylinder no more than -1.50D
- be accompanied by parents/guardians who can read and comprehend Vietnamese and give informed consent as demonstrated by signing a record of informed consent.
- be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
- have ocular health findings considered to be "normal".
- be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
- be willing to wear the spectacles provided by the investigators for all waking hours;
Exclusion
- A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics;
- Strabismus and/or amblyopia;
- Had previous eye surgery (including strabismus surgery);
- Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes;
- Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids;
- Worn bifocals or progressive addition spectacles;
- Worn orthokeratology or bifocal contact lenses;
- Current orthoptic treatment or vision training;
- Any anatomical, skin or other condition that would impact on the wearing of spectacles;
- Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
- Concurrently enrolled in another clinical trial.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04813640
Start Date
February 5 2021
End Date
October 31 2021
Last Update
May 7 2021
Active Locations (1)
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1
Hai Yen Eye Care Center
Ho Chi Minh City, Vietnam