Trials
Search / Trial NCT06431841

Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control

Launched by HOSPITAL SAN CARLOS, MADRID · May 21, 2024

Trial Information

Current as of February 14, 2025

Active, not recruiting

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • 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.
  • Exclusion criteria
  • 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.

About Hospital San Carlos, Madrid

Hospital San Carlos, located in Madrid, is a leading healthcare institution renowned for its commitment to advancing medical research and improving patient outcomes. As a prominent clinical trial sponsor, the hospital is dedicated to conducting innovative studies that adhere to the highest ethical and scientific standards. With a multidisciplinary team of experienced researchers and clinicians, Hospital San Carlos aims to explore novel therapeutic approaches and contribute to the development of cutting-edge treatments across various medical fields. Its strategic collaborations and robust infrastructure enable the hospital to effectively facilitate clinical trials, ultimately enhancing the quality of care provided to patients.

Locations

Madrid, , Spain

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0