Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control (NCT05894382) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control
China236 participantsStarted 2023-06-03
Plain-language summary
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.
Who can participate
Age range
6 Years – 13 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
. Race: Chinese children and adolescents.
. Age 6-13 years, gender unrestricted.
. Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
. Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
. Refractive astigmatism and astigmatism are no more than 1.5D.
. During the study period, willing to wear glasses provided by the researcher only (\>10 hours) and without additional interventions.
. Willing to be randomly assigned.
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.
1This trial is studying a special 'Double Helix Design Defocus Lens' spectacle for slowing myopia progression — is this type of lens something my doctor thinks could be appropriate to discuss for my situation, and how does it compare to other myopia control options like orthokeratology or atropine drops?
2The trial is measuring 'spherical equivalent change,' which tracks how much the prescription is shifting over time — can my doctor explain what my current rate of prescription change looks like, and whether that makes participating in a study like this worth exploring?
3The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new participants — does my doctor know of any similar or follow-up studies I might actually be eligible for, or whether these lenses are available outside of a trial setting?
4Since this trial has no assigned phase, there may still be questions about how well the safety and effectiveness data will generalize — what does my doctor think about the current evidence base for defocus lens spectacles compared to more established myopia control treatments?
5Wearing a specific study spectacle lens every day could affect my child's or my own daily routine and visual comfort — based on what my doctor knows about defocus lens designs, are there practical considerations about adaptation or vision quality I should think through before pursuing this kind of treatment?
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
1
Spherical Equivalent change
Timeframe: 1 year
Trial details
NCT IDNCT05894382
SponsorShanghai Eye Disease Prevention and Treatment Center
. Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.
Exclusion criteria
. Allergic or intolerant to medications used for ciliary muscle paralysis.
. Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study.
. Received defocus lenses for nearsightedness treatment in the past.
. Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
. History of eye surgery (including strabismus correction surgery).
. Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
. Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.