UnknownNot Applicable

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

China60 participantsStarted 2023-08-01

Plain-language summary

The purpose of this clinical study is to confirm the effectiveness and safety of low-level monochromatic red-light for high myopia control in adults

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 18 and 40 years, regardless of gender.
. 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.
. Normal cognitive abilities and language communication skills, capable of actively cooperating with the required treatment.
. Absence of contraindications for atropine use, such as acute ocular inflammation, dry eye, keratoconus, and diabetes.
. Written informed consent obtained from the patients.

Exclusion criteria

. History of photoallergy, glaucoma, trichiasis syndrome, ocular hypertension, fundus macula lesions, or eye injuries.
. Corneal curvature examination revealing an average K value of the anterior corneal surface of ≥45.
. Presence of systemic diseases (e.g., heart, liver, kidney diseases) and congenital hereditary myopia.
. Chronic eye diseases, including ocular trauma, strabismus, or previous ocular surgery, as well as allergic conjunctivitis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in axial length of the left and right eyes

Timeframe: baseline, 30days, 90 days, 180 days

Trial details

NCT IDNCT05947019

SponsorShanghai Eye Disease Prevention and Treatment Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

Contact for this trial

He Jiangnan

021-62539696 hejiangnan85@126.com

View on ClinicalTrials.gov More High Myopia trials