Actively Recruiting
Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children
Led by nthalmic Pty Ltd · Updated on 2025-04-17
210
Participants Needed
5
Research Sites
140 weeks
Total Duration
On this page
Sponsors
N
nthalmic Pty Ltd
Lead Sponsor
Z
Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.
CONDITIONS
Official Title
Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 6 and 14 years old inclusive at time of enrolment
- Child has read, understood, and signed the Informed Assent
- Parent or legal guardian has read, understood, and signed the Informed Consent
- Child and parent/guardian can understand the study and agree to follow study requirements
- Agree to maintain visit and wearing schedule
- Agree to wear allocated spectacles at least 5 days per week for 6 hours per day during the study
- Possess wearable and visually functioning spectacles
- Be in good general health as known by parent or guardian
- Best-corrected visual acuity of 0.10 logMAR (20/25) or better in each eye
- Meet baseline cycloplegic autorefraction criteria: spherical equivalent between -5.00 D and -0.75 D, sphere component -0.50 DS, astigmatism between -1.50 DC and 0 DC, and anisometropia 1.00 D
You will not qualify if you...
- Currently or within 30 days prior participating in another study
- Current or prior use of any myopia control treatments including bifocal/multifocal spectacles or contact lenses, orthokeratology, atropine >0.01%, or pirenzepine
- Born earlier than 30 weeks gestation or birth weight under 1500 g
- Habitual use of medications affecting eye health or physiology
- Known allergy to fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate
- Strabismus (eye misalignment) detected by cover test
- Known ocular or systemic diseases such as diabetes, Graves' disease, glaucoma, uveitis, scleritis, and autoimmune diseases like multiple sclerosis or lupus
- Ocular, systemic, or neuro-developmental conditions affecting refractive development such as cataract, corneal scarring, Marfan's syndrome, Down's syndrome, or retinopathy of prematurity
- Keratoconus or irregular cornea
- Investigator discretion if participant cannot meet trial requirements or it is in their best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Tianjin Eye Hospital
Tianjin, Heping District, China, 300020
Actively Recruiting
2
Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, China, 200031
Actively Recruiting
3
Divyajyoti Trust Tejas Eye Hospital
Surat, Gujarat, India, 394 160
Actively Recruiting
4
LV Prasad Eye Institute
Hyderabad, Telangana, India, 500034
Actively Recruiting
5
Pristine Eye Hospitals
Hyderabad, Telangana, India, 500081
Not Yet Recruiting
Research Team
D
Daniel Tilia, MOptom, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here