A Randomized Controlled Clinical Study Evaluating the Effectiveness, Safety, and Comfort of Photolithography Microstructure Lenses for Managing Myopia in Children and Adolescents
Phase: NA
Conditions: Myopia, Child Myopia Progression
Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study Protocol  
Randomized Controlled Clinical Study on the Effectiveness 
and Wearing Safety and Comfort of Photolithographic 
Microstructure Myopia Management Lenses in Myopia 
Prevention and Control among Children and Adolescents 
 
 
 
 
 
 
Research Institution 
Shanghai Eye Diseases Prevention &Treatment 
Center 
Project Leader 
Wei Xu, Xiaofeng Zhu 
Sponsoring Institution 
Nantong Nuotong Yimu Medical Technology 
Co., Ltd 
Project No. 
QX-2025-A-020 
Ethics Number 
IIT2025-029-RE-01 
Date 
December 10, 2025 
 
 
 
 
 

Indications: 
Ages 6-14; after cycloplegia, both eyes with spherical equivalent between -0.50D and 
-4.00D; cylindrical lens ≤1.50D in both eyes; anisometropia ≤1.50D; best corrected 
visual acuity ≥5.0; subjects willing to undergo treatment. 
 
Study Product: 
Photolithographic microstructure myopia management lenses 
 
Study Objectives: 
Primary objective: To evaluate the effectiveness of different photolithographic 
microstructure myopia management lenses in controlling myopia progression in 
children and adolescents, as well as the safety and comfort of wearing them; to 
explore effective defocus microlens designs for myopia control and the feasibility of 
applying photolithographic microstructure myopia management lenses in myopia 
prevention and control. 
Secondary objective: To understand and analyze the diagnosis and treatment status 
of myopia prevention and control in children and adolescents and related influencing 
factors such as age at onset, gender, wearing duration, and visual habits. 
 
Study Design: 
1. Prospective, single-center, randomized, double-blind controlled clinical trial. 

2. Initial and follow-up visits conducted by designated optometrists/physicians who 
will record patients’ basic information, visual acuity, objective and subjective 
refraction results before and after cycloplegia, axial length, and other biometric and 
special examination data. 
3. Subjects aged 6 years and older, diagnosed by investigators as suitable for 
photolithographic microstructure myopia management lenses. 
4. Observation period of 1 year with daily wear of at least 12 hours. Baseline at 
enrollment and follow-ups every 3 months thereafter. The right eye will be the study 
eye. Observations include visual acuity, spherical equivalent refraction, axial length, 
corneal curvature, pupil diameter, multispectral refraction topography (defocus 
measurement), amplitude of accommodation, contrast sensitivity, etc. 
 
Study Duration: 
18 months total, including a 6-month recruitment and screening period and a 12-
month trial period. 
 
Sample Size: 
This is a non-inferiority study comparing three experimental groups with a control 
group at a 1:1:1:1 ratio. The Dunnett method will be used to control the overall type I 
error, with a significance level α=0.0094 (one-sided) for the primary efficacy endpoint 
hypothesis test. 

Reference is made to the study by Professor Zhou Xingtao and Professor Chen Zhi’s 
team at Fudan University Eye and ENT Hospital on the Starfun Control Plano 
Defocus Lens (American Journal of Ophthalmology, AJO, 2024). The 12-month 
difference in spherical equivalent (SE) progression between the Starfun Control Plano 
Defocus Lens (highly aspherical lenslets, HAL group) and ordinary single-vision plano 
lenses (SV group) was 0.21D (SV group -0.25D vs. HAL group -0.04D), representing 
the core efficacy difference of Starfun Control technology compared to no myopia 
control treatment. Based on clinical statistical principles for non-inferiority margins 
and expert recommendations, the non-inferiority margin δ is set at -0.12D. 
Accordingly, this study sets the non-inferiority margin δ = -0.12D, with a nominal α 
of 0.0094 (one-sided) for any paired test, standard deviation SD = 0.18D, and power 
of 85%. Randomization is at a 1:1:1:1 ratio. Using PASS software, the minimum 
sample size per group is 53 subjects. Considering an approximate 15% loss to follow-
up, each treatment group requires 63 subjects, totaling 252 subjects. 
Non-inferiority is established if the lower bound of the two-sided 98.12% confidence 
interval for the change from baseline in cycloplegic refraction spherical equivalent 
(SE) in any experimental group compared to the control group is greater than δ. 
 
Inclusion Criteria: 
1. Age 6-14 years; 

2. After cycloplegia with 1% cyclopentolate hydrochloride eye drops (Saifeijie), both 
eyes with spherical equivalent between -0.50D and -4.00D; cylindrical lens ≤1.50D; 
anisometropia ≤1.50D; best corrected visual acuity better than 5.0; 
3. No use of multifocal glasses, orthokeratology lenses, defocus soft lenses, 
progressive lenses, atropine eye drops, red light therapy, acupuncture, or other myopia 
control methods within the past 3 months; 
4. Subject willing to undergo treatment and legal guardian has signed informed 
consent. 
 
Exclusion Criteria: 
1. Diagnosed constant strabismus; 
2. Diagnosed pathological myopia; 
3. Other congenital eye diseases; 
4. Other reasons deemed unsuitable for inclusion by the study physician. 
 
Study Endpoints: 
Non-inferiority 
Primary Endpoint: 
Change from baseline in cycloplegic refraction spherical equivalent (SE, diopters) 
Secondary Endpoints: 
Change from baseline in axial length (AL, millimeters) 
Change from baseline in choroidal thickness (ChT, micrometers) 

Exploratory Endpoints: 
Other biological parameters including anterior chamber depth (ACD), horizontal and 
vertical corneal curvature (CC), corneal diameter (white-to-white distance, WTW), 
central corneal thickness (CCT), pupil size, multispectral refraction topography 
(MRT), amplitude of accommodation, contrast sensitivity, etc. 
Best corrected visual acuity (BCVA) 
Daily lens wearing time and other data collected via questionnaire 
 
Safety: 
Safety, comfort, and acceptability of lens wear as reported by subjects through 
questionnaires