A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
Not Applicable
Completed
- Conditions
- Myopic Progression
- Interventions
- Device: Orthokeratology
- Registration Number
- NCT02643342
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
This is a two-year longitudinal study investigating the optical and structural effects of increased compression factor of orthokeratology lens on eyes and the corresponding effect on change in choroidal thickness and therefore myopic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
Inclusion Criteria
- 6 to 10 years old
- Myopia: between 0.50 D and 4.00 D in both eyes
- Astigmatism: <1.50 D; ≤ 1.25 D for with-the-rule astigmatism (axes 180 ± 30); ≤ 0.50 D for astigmatism of other axes in both eyes
- Anisometropia: ≤ 1.50 D
- Symmetrical corneal topography with corneal toricity <2.00 D in both eyes
- Agree for randomization
Exclusion Criteria
- Contraindications for orthokeratology wear (e.g. limbus-to-limbus corneal cylinder and dislocated corneal apex)
- Any type of strabismus or amblyopia
- Myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period
- Rigid contact lenses (including orthokeratology lenses) experience
- Systemic condition which might affect refractive development (for example, Down syndrome, Marfan's syndrome)
- Ocular conditions which might affect the refractive error (for example, cataract, ptosis)
- Poor compliance for lens wear or follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orthokeratology with normal compression factor Orthokeratology Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D. Orthokeratology with increased compression factor Orthokeratology Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D.
- Primary Outcome Measures
Name Time Method Axial length every 6 monthly in 2 years axial progression of the eyeball
- Secondary Outcome Measures
Name Time Method Choroidal thickness captured by Optical Coherent Tomographer (OCT) every 6 monthly in 2 years choroidal thickness captured by Optical Coherent Tomographer (OCT) and measured using a customized software
Ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer every 6 monthly in 2 years ocular aberration measured by Complete Ophthalmic Analysis System (COAS) aberrometer
Corneal biomechanics (corneal response using ocular response) every 6 monthly in 2 years corneal response using ocular response
Accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer every 6 monthly in 2 years accommodation lag measured by Complete Ophthalmic Analysis System (COAS) aberrometer using different accommodation targets
Trial Locations
- Locations (1)
School of Optometry, The Hong KOng Polytechnic University
🇨🇳Hong Kong, China