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

Keywords

ClinConnect Summary

The ASPECT trial is a research study looking at how well a combination treatment of atropine eye drops and special spectacle lenses can help control the worsening of myopia (nearsightedness) in children. The study is focused on children aged 4 to 16 who have been diagnosed with myopia that is getting worse. To participate, kids need to have a certain level of myopia and show that their vision has changed in the past year. This trial is comparing two groups: one group will receive atropine drops along with special DIMS lenses designed to slow myopia progression, while the other group will receive the same drops with regular single vision lenses.

Participants in the trial can expect regular eye check-ups to monitor their vision over a 12-month period. The study is currently active and has already enrolled a total of 111 children. It's important to note that certain conditions, like previous eye surgeries or specific eye problems, may prevent a child from participating. If you think your child might be eligible and you're interested in learning more, it's a good idea to discuss it with your eye care provider.

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.