Trial · NCT07028827
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Vision-related quality of life (VLSQ-8). | Baseline, 6, 12 and 24 months | Patient-reported assessment of vision-related quality of life using validated questionnaire (Self-reported, Visual Light Sensitivity Questionnaire-8 - VLSQ-8) at specified time points. |
| Secondary | Acceptability of atropine formulation. | 3, 6, 12, 18 and 24 months | Assessment of acceptability of the formulation using a 3-item questionnaire, scored on a six-point scale. The questionnaire consists of a survey investigating ocular symptoms and discomforts after eye drops instillation. |
| Secondary | Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER). | 24 months | Comparison of the proportion of subjects in each treatment group who show myopia progression (SER) of less than -0.50 D at 24 months. Statistical analysis will include a Chi-square test or Fisher's exact test to evaluate between-group differences. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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