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Analysis of success rate, effectiveness and safety of digital software fitting orthokeratology lenses

Analysis of success rate, effectiveness and safety of digital software fitting orthokeratology lenses

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113940
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-07
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Myopia

Interventions

Control group:The control group will undergo intervention with orthokeratology (OK) lenses prescribed entirely by the fitting physician
Test group:Orthokeratology (OK) lenses prescribed by the digital software ("Eye Lite" fitting software).

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Age: 8-12 years; 2.The refractive error spherical power after ciliary muscle paralysis in both eyes ranges from -1.00D to -4.00D, with astigmatism = -1.50D, and the difference in spherical equivalent between the two eyes < 1.00D; 3.Best corrected visual acuity in both eyes = 1.0; 4.Corneal curvature between 40.00D and 46.00D; 5.Able to complete the examination and follow-up on time; 6.The subjects and project participants have carefully read and agreed to the contents of the informed consent form, and both parties have signed;

Exclusion criteria

Exclusion criteria: 1.One of the following ocular surface abnormalities: trachoma, pemphigoid, chemical injury, thermal burn, radiation injury, etc. 2.Abnormalities of the eyelid (such as entropion, ectropion, tumors, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) affecting the eyelid function of either eye; 3.Ocular conditions such as strabismus, amblyopia, anisometropia, fundus disease, and accommodative abnormalities; 4.No use of other myopia control methods for the past 3 months, such as peripheral defocus or frame lenses that reduce contrast sensitivity, atropine eye ointment, low-concentration atropine eye drops, phototherapy devices, reverse photography, etc; 5.Examination results indicate contraindications or unsuitability for wearing rigid gas-permeable corneal contact lenses, such as corneal endothelial cell density less than 2800 cells/mm²; 6.Intolerance to corneal contact lenses; 7.The investigator determines that the subject is unable to comply with the study requirements;

Design outcomes

Primary

MeasureTime frame
Fitting Success Rate;

Secondary

MeasureTime frame
Axial length;Visual acuity without lens;Change in Central Curvature of the Treatment Zone;Corneal Endothelial Cell Count;Choroidal Thickness;

Countries

China

Contacts

Public ContactYang Chenhao

Children's Hospital of Fudan University

ychben@hotmail.com+86 21 64931715

Outcome results

None listed

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