ATROPINE SULFATE for Myopia

Inclusion criteria

• {"criterion_text":"- Patients between 4-16 years old\n- Informed consent signed by parents or tutors for all patients and for patients aged 12-16 years. Assent in children under 12 years old\n- Refractive defect: myopia greater than -1.00 dioptres (D)\n- Myopia progression of at least -0.50 D in the last 12 months\n- Astigmatism of 2 D or less and anisometropia of 1.50 D or less\n- Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better"}

Exclusion criteria

• {"criterion_text":"- Children under 4 years old and over 16 years old\n- Strabismus and binocular vision anomalies\n- Alterations in eye fundus that the researcher consider necessary the patient exclusion\n- 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\n- Amblyopia\n- Previous ocular surgery\n- 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)\n- 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"}

Primary endpoints

• {"endpoint_text":"- Change in refractive error after cycloplegia (with 1% cyclopentolate 3 drops 10 minutes apart; measured after 30 minutes) relative to baseline values.","definition_or_measurement_approach":"Measured after cycloplegia with 1% cyclopentolate: 3 drops 10 minutes apart; measurement after 30 minutes; change relative to baseline values."}
• {"endpoint_text":"- Proportion of patients presenting adverse events","definition_or_measurement_approach":"Proportion of participants reporting adverse events (no further measurement detail provided)."}

Secondary endpoints

• {"endpoint_text":"- Change in axial length in millimetres, relative to baseline values","definition_or_measurement_approach":"Change in axial length measured in millimetres relative to baseline values."}
• {"endpoint_text":"- Change in choroidal and retinal thickness measured on Optical Coherence Tomography (OCT) in μm, relative to baseline values","definition_or_measurement_approach":"Choroidal and retinal thickness measured by OCT in micrometres (μm), change relative to baseline values."}
• {"endpoint_text":"- Change in intraocular pressure in mmHg, relative to baseline values","definition_or_measurement_approach":"Intraocular pressure measured in mmHg, change relative to baseline values."}

Spain

Earliest CTIS Part Ii Submission Date

15-07-2024

Latest Decision Or Authorization Date

18-07-2024

Processing Time Days

3

Number Of Sites

1

Number Of Participants

111

Primary sponsor

Full Name

Hospital Clinico San Carlos

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain