Clinical trial NCT05894382: Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control
Official title: A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 264
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Race: Chinese children and adolescents.
2. Age 6-13 years, gender unrestricted.
3. Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
4. Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
5. Refractive astigmatism and astigmatism are no more than 1.5D.
6. During the study period, willing to wear glasses provided by the researcher only (\>10 hours) and without additional interventions.
7. Willing to be randomly assigned.
8. Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.

Exclusion Criteria:

1. Allergic or intolerant to medications used for ciliary muscle paralysis.
2. 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.
3. Received defocus lenses for nearsightedness treatment in the past.
4. 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.).
5. History of eye surgery (including strabismus correction surgery).
6. Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
7. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
8. 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.

Primary outcomes:
measure: Spherical Equivalent change
timeFrame: 1 year
Secondary outcomes:
measure: Axial Length change
timeFrame: 1 year
measure: Visual Acuity change
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiangui He
state: Shanghai
Study officials:
References: