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Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population
EU CTIS ID: 2024-514651-15-00
What this study is testing
To determine the efficacy and safety of the combined use of diluted atropine eye drops 0.025% and DIMS technology ophthalmic lenses in the control of myopia progression in the paediatric population.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients between 4-16 years old
- Informed consent signed by parents or tutors for all patients and for patients aged 12-16 years. Assent in children under 12 years old
- Refractive defect: myopia greater than -1.00 dioptres (D)
- Myopia progression of at least -0.50 D in the last 12 months
- Astigmatism of 2 D or less and anisometropia of 1.50 D or less
- Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better
You likely can't join if
- Children under 4 years old and over 16 years old
- Strabismus and binocular vision anomalies
- Alterations in eye fundus that the researcher consider necessary the patient exclusion
- Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
- Amblyopia
- Previous ocular surgery
See the full eligibility criteria
- Patients between 4-16 years old
- Informed consent signed by parents or tutors for all patients and for patients aged 12-16 years. Assent in children under 12 years old
- Refractive defect: myopia greater than -1.00 dioptres (D)
- Myopia progression of at least -0.50 D in the last 12 months
- Astigmatism of 2 D or less and anisometropia of 1.50 D or less
- Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better
- Children under 4 years old and over 16 years old
- Strabismus and binocular vision anomalies
- Alterations in eye fundus that the researcher consider necessary the patient exclusion
- Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision
- Amblyopia
- Previous ocular surgery
- Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline condition of the patient that does not allow the examination to be performed (such as mental or psychomotor retardation)
- Previous treatments for myopia control, including orthokeratology, rigid contact lenses, bifocal soft contact lenses or for myopia control, bifocal and multifocal ophthalmic lenses in the 3 months prior to the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.