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NCT05894382
Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control
NA trial testing Double Helix Design Defocus Lens Spectacle (RACE) in Myopia, Progressive in 236 participants. Participants enrolled and being followed up; not accepting new ones.
31 August 2026
Quick facts
| Lead sponsor | Shanghai Eye Disease Prevention and Treatment Center |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 236 |
| Start date | 3 June 2023 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Double Helix Design Defocus Lens Spectacle (RACE)
- single-vision spetacle lens
Conditions studied
- Myopia, Progressive — all drugs for Myopia, Progressive →
Sponsor
Shanghai Eye Disease Prevention and Treatment Center — full company profile →
Who can join
Adults 6 to 13, any sex, with Myopia, Progressive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05894382
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myopia, Progressive
Currently open trials in the same condition.
- NCT06927388 — Myopia Progression With Freeform Myopia Control Spectacles · NA · active not recruiting
- NCT07055815 — Impact of Digital Screen Time in Progression of Myopia in Children · active not recruiting
- NCT06389110 — Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elo · Phase 3 · recruiting
- NCT06647160 — Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control · NA · active not recruiting
- NCT06520124 — Stellest Lens Wear in Adult Progressing Myopes · NA · active not recruiting
Other Shanghai Eye Disease Prevention and Treatment Center trials
Trials by the same sponsor.
- NCT07535658 — Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control · NA · not yet recruiting
- NCT07514039 — Photolithography Microstructure Myopia Management Lenses in Preventing and Controlling Myopia in Children and Adolescent · NA · enrolling by invitation
- NCT07312214 — LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia · NA · recruiting
- NCT07284147 — 3D Designed Defocus Lenses on Myopia Control in Children and Adolescents · NA · enrolling by invitation
- NCT07120737 — Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX Technology on High Myopia Control in Children and Adolescents · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05894382 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Eye Disease Prevention and Treatment Center
- Last refreshed: 8 December 2025
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