Not yet recruiting NCT06765603
Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atropine 0.025%, Multizonal contact lens, Placebo, Single vision Contact lens.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 7 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.
Detailed description
see above
Interventions
- Drug Atropine 0.025%
Atropine 0.025% - Device Multizonal contact lens
Multizonal CL - Drug Placebo
Placebo - Device Single vision Contact lens
Single vision contact lens
Primary outcome measures
- Change in spherical equivalent [Time frame: 12 months]
Secondary outcome measures (1)
- Change in axial length [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Between 7 and 12 (inclusive) years of age at the time of screening.
- spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.
- Refractive cylinder less than 1.12 D (inclusive)
- Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.
- Have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion criteria
- Past or current use of myopia control treatment or involvement in previous myopia control study
- Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).
- hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.
- previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
- Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit-lamp findings (eg. edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
- Any central corneal scar or corneal distortion resulting from ocular diseases or previous hard or rigid permeable contact lens wear.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06765603 · R1867/109/2021