Control of Myopia in Young Children Using H.O.P.E. Lenses Combined With 0.02% Atropine Eye Drops
ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorRuihua Wei
About this trial
A multicenter, prospective, intervention study on the control of myopia in young children using high-order phase element array microstructure lenses (H.O.P.E.) in combination with low-concentration atropine eye drops (0.02%)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 6-9 years old (6 years old but under 10 years old), gender not restricted;
Clinically diagnosed with bilateral myopia (after cycloplegia), refractive error within -6.00D < SER ≤ -0.50D, astigmatism ≤ 1.50D, refractive anisometropia ≤ 1.50D (based on subjective refraction values);
Corrected visual acuity LogMAR ≤ 0.1;
Able to understand the research purpose, voluntarily participate, and the subject and his/her legal guardian sign the informed consent form.
Disqualifiers
Those who have discontinued the use of atropine eye drops (due to glaucoma or a tendency towards glaucoma, or are allergic to scopolamine or the components of this product);
Those currently suffering from any of the following diseases that may affect vision or refractive errors, or ocular organic diseases: such as diseases causing damage to the lens like cataracts, glaucoma, macular degeneration, corneal diseases, uveitis, retinal detachment, severe vitreous opacity, acute/chronic keratitis, conjunctivitis, irregular cornea, keratoconus, manifest strabismus, fundus diseases, etc.; systemic diseases that may affect the eyes, such as immune system diseases, central nervous system diseases, Down syndrome, asthma, epilepsy, severe heart or lung function disorders, severe liver or kidney function impairments, etc.;
Those who have participated in other clinical trials or studies related to myopia control within 90 days before signing the informed consent form;
Those who have used myopia control products within 90 days before signing the informed consent form (such as near-axial lenses, low-concentration atropine eye drops, corneal reshaping lenses, red light, etc.);
Trial design
Design model
Parallel
Treatments tested in this trial
High-order Phase Element Array Microstructure Design Lens (H.O.P.E.)
DeviceWear the H.O.P.E. lens frame glasses and use the placebo. Use it once per night for both eyes.
0.02% Atropine Sulfate Eye Drops
DrugWear single-vision frame glasses and use 0.02% atropine sulfate eye drops twice a day, once at night for both eyes.
Treatment groups
264 Participants
are divided into 3 treatment groupsGroup A: Group A (H.O.P.E. Lens Group)Active comparator 1 intervention
Group B: Group B (0.02% Atropine group)Active comparator 1 intervention
Group C: Group C (H.O.P.E. lenses + 0.02% atropine group)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The final spherical equivalent refractive error (SER) measured by cycloplegic refraction combined with both automated and subjective refraction after 12 months of wearing glasses, compared with the baseline value.
Time frame
From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
The change in AL (axial length) from the baseline after wearing the glasses for 12 months
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruihua Wei
Lead sponsor
Tianjin Medical University Eye Hospital
Sponsor institution
Tianjin Medical University Eye Hospital
Collaborator
Source ClinicalTrials.gov
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