Stellest Lenses and Low-concentration Atropine Myopia Control Among Children

NCT06344429 | Recruiting DMC

• 1 other identifier: STL_CT_0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the young population suffers from myopia, and almost 20% have high myopia. High myopia can easily lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma. In Taiwan, according to a survey by the National Health Administration, the proportion of myopia among Grade 1 students has exceeded 81%. There are many ways to control myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine. Multiple animal experiments have confirmed that giving retinal myopia defocus signals can effectively decrease the growth of the eye, thereby inhibiting the progression of myopia. Therefore, regarding lens design, myopic defocus does play an important role in myopia control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral defocus lenses. Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest significantly slowed down the myopia progression reaching 67% and retard axial elongation reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in controlling myopia in Taiwanese children and whether Stellest Lenses combined with low-concentration atropine eye drops can increase the effect of myopia control.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Spherical equivalent refraction power

  Spherical equivalent (SE) was calculated as spherical power plus half of the cylinder power

  At 2 weeks (monitor visit), 6 months, and 12 months from the baseline visit

• Axial length

  Ocular AL was measured by on non contact partial coherence interferometry and optic coherence tomography.

  At 2 weeks (monitor visit), 6 months, and 12 months from the baseline visit

Study Arms (3)

Stellest lenses spectacle

EXPERIMENTAL

34 children wear Stellest lenses for all day.

Device: Stellest Lenses

Stellest lenses+0.05% atropine

EXPERIMENTAL

33 children wear Stellest lenses for all day, and 0.05% atropine eye drops is dropped once nightly in both eyes.

Combination Product: Stellest Lenses+0.05% atropine

Single vision lenses+0.05% atropine

PLACEBO COMPARATOR

33 children wear Single lenses for all day, and 0.05% atropine eye drops is dropped once nightly in both eyes.

Drug: Single vision Lenses+0.05% atropine

Interventions

Stellest Lenses DEVICE

All subjects are recruited and randomized to 3 treatment groups at the baseline visit. A Group：Stellest Lenses spectacle (ST)

Stellest lenses spectacle

Stellest Lenses+0.05% atropine COMBINATION_PRODUCT

All subjects are recruited and randomized to 3 treatment groups at the baseline visit. B Group：Combined Treatment

Stellest lenses+0.05% atropine

Single vision Lenses+0.05% atropine DRUG

All subjects are recruited and randomized to 3 treatment groups at the baseline visit. C Group：0.05% Atropine with single vision

Single vision lenses+0.05% atropine

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6\~12 year-old.
• Equivalent diopter: -0.75\~-4.00 D.
• Astigmatism and anisometropia \<2.50 D.
• Best corrected visual acuity of one eye reaches 1.0.

You may not qualify if:

• Strabismus, amblyopia, and abnormal binocular vision.
• Other eye diseases.
• Have a history of using myopia control products within six months.

Sponsors & Collaborators

• Essilor-Polylite Taiwan Co., Ltd.: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833401, Taiwan

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Eric Tsai

CONTACT

+886 2-2528-8001; erictsai@essilor.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 3, 2024
• Study Start: August 20, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

TW (1)