Dual-Action Lenses for Slowing Myopia in Children and Teens: A Randomized, Double-Blind Trial

NCT07854457 | Not Yet Recruiting

• 1 other identifier: QX-2026-A-015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, double-blind, controlled study to test whether a new type of eyeglass lens - a "dual-action" lens that combines two technologies (multiple defocus zones and dot diffusion) - can slow the progression of nearsightedness (myopia) in children and teenagers. About the participants: Children and adolescents with myopia who meet the study requirements will be randomly assigned (like flipping a coin) to one of two groups. One group will wear the new dual-action lenses, and the other group will wear Stellest lenses, an established myopia-control lens. Neither the participants, their families, nor the eye doctors doing the follow-up exams will know which lens each child is wearing. About the study: Participants wear their assigned glasses at least 12 hours every day for 12 months and visit the clinic about every 3 months (5 visits in total). At each visit, doctors check eyesight, measure the length of the eyeball, and perform other eye exams. The main goal is to compare how much myopia progresses in the two groups after 12 months, measured by a painless dilated-eye (cycloplegic) refraction test. The study also tracks how comfortable and acceptable the lenses are, and how long children actually wear them each day. Why this research matters: Myopia in children is increasing worldwide, and effective ways to slow it down are still limited. This study will show whether combining two proven optical technologies in one lens works as well as existing options and is safe and comfortable for daily wear.

Conditions

Myopia; Refractive Errors

Keywords

myopia; Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Change in Cycloplegic Spherical Equivalent (SE) From Baseline at 12 Months

  The primary efficacy outcome is the change in spherical equivalent (SE, in diopters) measured by cycloplegic (dilated-eye) refraction from baseline to Month 12. SE is calculated as sphere + ½ × cylinder. Cycloplegic refraction is performed after administration of cycloplegic eye drops, using the same autorefractor and standardized procedure at each visit. A smaller change (less myopic shift) indicates better myopia control. The right eye is designated as the study (observation) eye.

  Baseline and Month 12

Secondary Outcomes (1)

• Change in Axial Length (AL) From Baseline at 12 Months

  Baseline and Month 12

Other Outcomes (2)

• Corneal Curvature

  Baseline and Months 3, 6, 9, 12

• Exploratory Analysis of Factors Associated With Myopia Progression and Myopia-Control Practice

  Collected at baseline and throughout the 12-month study period

Study Arms (2)

Dual-Action Lenses

EXPERIMENTAL

Device: Dual-Action Myopia-Control Spectacle Lens

Stellest Lenses

ACTIVE COMPARATOR

Participants in this arm wear Stellest myopia-control spectacle lenses, an established myopia-control lens with highly aspherical lenslet target (HALT) technology that is already marketed. Participants are instructed to wear the assigned lenses at least 12 hours per day for 12 months. The follow-up schedule and examinations are identical to those in the experimental arm. Neither the participants, their guardians, nor the follow-up examiners know which lens is being worn.

Device: Stellest Myopia-Control Spectacle Lens（Highly Aspherical Lenslet Target / HALT Lens）

Interventions

Dual-Action Myopia-Control Spectacle Lens DEVICE

Spectacle lenses that combine two myopia-control optical technologies in a single lens: multiple defocus zones (multipoint peripheral defocus design) and dot diffusion technology (a light-scattering treatment that reduces contrast of the peripheral retinal image). The two technologies are intended to act together to slow axial elongation and myopia progression. Lenses are worn as daily-wear spectacles, with participants instructed to wear them at least 12 hours per day throughout the 12-month study period. This lens is investigational and not currently marketed.

Dual-Action Lenses

Stellest Myopia-Control Spectacle Lens（Highly Aspherical Lenslet Target / HALT Lens） DEVICE

Stellest spectacle lenses incorporate Highly Aspherical Lenslet Target (HALT) technology: a constellation of highly aspherical micro-lenslets distributed across the lens surface, which creates a volume of myopic defocus in front of the retina to slow eye growth. Lenses are worn as daily-wear spectacles, with participants instructed to wear them at least 12 hours per day throughout the 12-month study period. Stellest is an established, marketed myopia-control lens used here as the active comparator.

Stellest Lenses

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-14 years.
• After cycloplegia with 1% cyclopentolate hydrochloride eye drops (Cyclogyl/Saifeijie), spherical equivalent (SE) of both eyes between -0.50 D and -4.00 D.
• Astigmatism of both eyes ≤ 1.50 D; anisometropia ≤ 1.50 D. Best-corrected visual acuity (BCVA) ≥ 5.0.
• No use of myopia-control methods within the past 3 months, including defocus lenses, dot diffusion lenses, orthokeratology lenses, defocus soft contact lenses, progressive-addition spectacles, atropine eye drops, red-light therapy, or acupuncture.
• Able and willing to wear the study lenses at least 12 hours per day.
• Able to attend all scheduled follow-up visits over 12 months (4 follow-up visits after baseline).
• Willing to participate, with written informed consent signed by the legal guardian.

You may not qualify if:

• Current or past glaucoma, corneal disease, or other organic eye diseases.
• Significant systemic disease, psychiatric disorder, or systemic collagen metabolic disease. Diagnosed amblyopia, constant strabismus, or other congenital eye diseases.
• Allergy to the materials or products of the study lenses.
• Allergy to cycloplegic agents or other ophthalmic examination medications.
• Unable to understand the study content or unable to cooperate with follow-up.
• Any other condition considered by the investigator to make the participant unsuitable for the study.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 201103, China

Location

Related Publications (3)

• Bao J, Yang A, Huang Y, Li X, Pan Y, Ding C, Lim EW, Zheng J, Spiegel DP, Drobe B, Lu F, Chen H. One-year myopia control efficacy of spectacle lenses with aspherical lenslets. Br J Ophthalmol. 2022 Aug;106(8):1171-1176. doi: 10.1136/bjophthalmol-2020-318367. Epub 2021 Apr 2.

  PMID: 33811039 BACKGROUND

• Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.

  PMID: 35357402 BACKGROUND

• Rappon J, Chung C, Young G, Hunt C, Neitz J, Neitz M, Chalberg T. Control of myopia using diffusion optics spectacle lenses: 12-month results of a randomised controlled, efficacy and safety study (CYPRESS). Br J Ophthalmol. 2023 Nov;107(11):1709-1715. doi: 10.1136/bjo-2021-321005. Epub 2022 Sep 1.

  PMID: 36126105 BACKGROUND

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

WEI XU Principal Investigator

CONTACT

+8618521513008; vvxuwei@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (1)