Efficacy and Safety of Low-Level Monochromatic Red-Light for High Myopia Control in Adults

Launched by SHANGHAI EYE DISEASE PREVENTION AND TREATMENT CENTER · Jul 7, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the use of low-level monochromatic red light to help control high myopia, which is a condition where people have very poor distance vision. The study aims to see if this light therapy is effective and safe for adults aged 18 to 40 who have significant myopia. To be eligible to join, participants need to have specific levels of vision impairment in at least one eye and be able to communicate and cooperate during the treatment process.

If you or someone you know is considering participating, it's important to note that participants will need to provide written consent and will be screened for certain health conditions, including any eye diseases or systemic health issues. The trial is not yet recruiting participants, but once it starts, those who qualify can expect to undergo treatment with the red light therapy and contribute to research that could help improve vision care for others with high myopia in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 40 years, regardless of gender.
• • 2. Presence of myopic refractive error in at least one eye, with myopic lens power after mydriasis exceeding 6.00D, diffusivity less than 2.00D, binocular anisometropia less than 3.00D, and best corrected distance visual acuity of at least 0.6, as well as near visual acuity of at least 0.6.
• • 3. Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment.
• • 4. Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes.
• • 5. Written informed consent obtained from the patients.
• Exclusion Criteria:
• • 1. History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries.
• • 2. Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45.
• • 3. Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia.
• • 4. Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis.
• • 5. Previous internal trichiasis, severe corneal opacity, conjunctival infection, or other eye diseases.
• • 6. Neurological diseases, allergies, or contraindications to atropine or other therapeutic drugs.
• • 7. Presence of immune system and systemic diseases such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, or diabetes.
• • 8. Epilepsy or mental disorders that hinder normal communication.
• • 9. Previous use of other treatments to control myopia progression, such as anticholinergic drugs like atropine within the past 3 months, or participation in other studies involving functional frame lenses, multifocal soft lenses, or similar interventions.
• • 10. Any other situation deemed unsuitable for participation in the study by the researcher.