Clinical trial NCT06647160: Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control
Official title: Safety and Efficacy of Blue Star MAX-5 Lenses in Mvopia Control: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Keywords: concentric columnar microstructure
Myopia control
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.


Eligibility criteria: Inclusion Criteria:

* Aged 8 to 11 years;
* Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
* Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen).
* The intraocular pressure of 10 to 21mmHg.
* Volunteer to participate in this clinical trial with signature of the informed consent form.

Exclusion Criteria:

* History of eye injury or intraocular surgery;
* Clinically abnormal slit-lamp findings
* Abnormal fundus examination
* Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
* Participation of the drug clinical trial within three month and the device clinical trial within one month;
* Only one eye meets the inclusion criteria;
* Unable to have regular follow-up
* Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Primary outcomes:
measure: Changes of spherical equivalent refraction (SER) at two years
timeFrame: 2 years
Secondary outcomes:
measure: Changes of axial length (AL) at two years
timeFrame: 2 years
measure: Visual scale score at two years
timeFrame: 2 years
measure: Incidence of adverse event during study period
timeFrame: 2 years
Other outcomes:
measure: Change of lens thickness (LT) at two years
timeFrame: 2 years
measure: Change of corneal power (CP) at two years
timeFrame: 2 years
measure: Best corrected visual acuity at two years
timeFrame: 2 years
measure: Binocular visual function at two years
timeFrame: 2 years
measure: Change of choroidal thickness at two years
timeFrame: 2 years
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Jian Ge
role: PRINCIPAL_INVESTIGATOR
References: