MyopiaPhase 4ASPECTNCT06431841
Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control
A Phase 4 study testing Atropine 0,025%, DIMS Lenses and Monofocal lenses in people with Myopia, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine 0,025%, DIMS Lenses and Monofocal lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2022to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 4-16 years.
- Signing of informed consent.
- Refractive error: myopia greater than -1.00 diopters (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.
Who cannot join
- 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 exclution.
- 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 eye surgery
- Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation)
- Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.
- Conditions
- Myopia
- Being tested
- Atropine 0,025%, DIMS Lenses, Monofocal lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0,025%Drug
Atropine 0,025% (1 drop per day)
DIMS LensesDevice
Use of peripheral defocus lenses with DIMS technology, the design of which simultaneously introduces myopic defocus and provides clear vision to the wearer at all viewing distances.
Monofocal lensesDevice
Use of monofocal lenses.
| Study group | Role | What they receive |
|---|---|---|
| DIMS Lenses | Experimental | Atropine 0,025% + DIMS Lenses Receives: Drug: Atropine 0,025%; Device: DIMS Lenses |
| Monofocal Lenses | Active comparator | Atropine 0,025% + monofocal (single vision) Lenses Receives: Drug: Atropine 0,025%; Device: Monofocal lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic spherical equivalent refraction (SER) change
Cycloplegic spherical equivalent refraction (SER) change
Measured: 2 years (24 months)
Axial length (AL) change
Axial length (AL) change
Measured: 2 years (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start23 Feb 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noemi Guemes, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431841
- Sponsor's protocol ID
- 21/522-EC_M
- Acronym
- ASPECT
- Status last verified
- Sep 2025
- First submitted
- 13 Mar 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06431841
- Acronym / sponsor ID
- ASPECT / 21/522-EC_M
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial with 2 arms, involving 111 patients in total. The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIMS Lenses | Experimental | Drug: Atropine 0,025%, Device: DIMS LensesAtropine 0,025% + DIMS Lenses |
| Monofocal Lenses | Active comparator | Drug: Atropine 0,025%, Device: Monofocal lensesAtropine 0,025% + monofocal (single vision) Lenses |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 4-16 years.
- Signing of informed consent.
- Refractive error: myopia greater than -1.00 diopters (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.
Key exclusion criteria (8 listed)
- 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 exclution.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine 0,025%Atropine 0,025% (1 drop per day) | Drug | DIMS Lenses, Monofocal Lenses |
| DIMS LensesUse of peripheral defocus lenses with DIMS technology, the design of which simultaneously introduces myopic defocus and provides clear vision to the wearer at all viewing distances. | Device | DIMS Lenses |
| Monofocal lensesUse of monofocal lenses. | Device | Monofocal Lenses |
Primary outcome
Cycloplegic spherical equivalent refraction (SER) change
Time frame: 2 years (24 months)
Cycloplegic spherical equivalent refraction (SER) change
Axial length (AL) change
Time frame: 2 years (24 months)
Axial length (AL) change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atropine 0,025%, DIMS Lenses and Monofocal lenses in people with Myopia, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic spherical equivalent refraction (SER) change (time frame: 2 years (24 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.