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Comparison of clinical effectiveness and safety between artificial intelligence fitting and empirical fitting of corneal orthokeratology lenses: a randomized controlled non-inferiority study

Comparison of clinical effectiveness and safety between artificial intelligence fitting and empirical fitting of corneal orthokeratology lenses: a randomized controlled non-inferiority study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089431
Enrollment
Unknown
Registered
2024-09-09
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Control group:Experiential fitting of corneal orthokeratology lens
Test group:Artificial intelligence fitting corneal orthokeratology lens

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 16 Years

Inclusion criteria

Inclusion criteria: 8-16 years old, regardless of gender; The refractive error range after bilateral ciliary muscle paralysis is -1.00D to -3.00D, with astigmatism = -1.50D, the difference between the equivalent spherical lenses of both eyes is less than 1.00D; The best corrected visual acuity for both eye frames is = 0.8; Both eyes are normal eyes with no other abnormalities or diseases except for refractive errors; Tear film rupture time = 8 seconds; The intraocular pressure is 10-21mmHg.

Exclusion criteria

Exclusion criteria: Within one month, systemic or local use of drugs such as atropine that may affect eye axis development; Have used or are currently using specially designed myopia control lenses (including defocused frame glasses, OK lenses, and defocused soft lenses, etc.) within one month; The examination results indicate contraindications or unsuitability for wearing rigid breathable contact lenses; Suffering from diabetes, asthma, low immunity and other systemic diseases; Corneal contact lens intolerance.

Design outcomes

Primary

MeasureTime frame
visual acuity;Topography;Axial Length;

Secondary

MeasureTime frame
Effective defocus volume of the entrance pupil;Corneal staining assessment;

Countries

China

Contacts

Public ContactYu Zhang

Peking University Third Hospital

1494867399@qq.com+86 139 1007 1022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026