Trial · NCT07028827
Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
NCT07028827, Phase 3, Recruiting, Ocus Innovation Ireland Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY). Trials, record NCT07028827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07028827
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atropine Eyedrops for Myopia Progression in Children and Adolescents (MODERATO STUDY)
- NCT number
- NCT07028827
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 234 participants, estimated
- Lead sponsor
- Ocus Innovation Ireland Limited
- Conditions
- Myopia
- Interventions
- 0.05% atropine eye drops, 0.025% atropine eye drops, placebo eye drops
- First posted
- 2025-06-19
- Last updated
- 2026-02-11
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean annual rate of progression of myopia | 24 months | The primary outcome measure evaluates the efficacy of atropine in slowing myopia progression in children and adolescents. The mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction over 24 months. |
| Secondary | Number and percentage of early escape patients. | 6 months | To assess the early escape rate in the placebo group. Patients who show significant myopia progression at the 6-month mark will be switched to atropine eye drops at the investigator's discretion. |
| Secondary | Mean change in axial length and glasses prescription. | 3, 6, 12, 18 and 24 months | Assessment of the mean change in axial length (mm) and glasses prescription over a longer period of time to investigate the efficacy of the intervention. |
| Secondary | Safety assessment of atropine. | 3, 6, 12, 18 and 24 months | Evaluation of safety by measuring the counts and percentage of patients reporting any adverse events. |
| Secondary | Use of photochromic and/or varifocal lenses. | 3, 6, 12, 18, and 24 months | Number and percentage of participants requiring the use of photochromic and/or varifocal lenses. |
| Secondary | Changes in photosensitivity index. | Baseline, 3, 6, 12, 18, and 24 months | Evaluation of changes in photosensitivity index, used to monitor treatment-induced light sensitivity over time. |
| Secondary | Best Corrected Visual Acuity. | 3, 6, 12, 18, and 24 months | Assessment of best corrected distance and near visual acuity using standardised methods appropriate for participant age. |
| Secondary | Pupil Diameter (PD) in photopic lighting condition. | 3, 6, 12, 18, and 24 months | Measurement of PD (in mm) under photopic and average lighting using a PD ruler or autorefractor. |
| Secondary | Accommodation amplitude. | 3, 6, 12, 18, and 24 months | Measurement of the accommodation amplitude (diopter) performed monocularly and binocularly over distance correction. |
| Secondary | Vision-related quality of life (SREEQ-R). | Baseline, 6, 12 and 24 months | Patient-reported assessment of vision-related quality of life using validated questionnaire (Student Refractive Error and Eyeglasses Questionnaire - Revised - SREEQ-R) at specified time points. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07028827
GET https://conductscience.org/api/trials/v1/NCT07028827/registered