A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye

The Hong Kong Polytechnic University

Status: Completed

Conditions: Myopic Progression

Treatments: Device: Orthokeratology

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02643342

HSEARS20150909002

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

99 participants in 3 patient groups

Single-vision glasses

No Intervention group

Description:

Subjects wearing single-vision glasses CR-39 of refractive index 1.56.

Orthokeratology with normal compression factor

Sham Comparator group

Description:

Subjects wearing orthokeratology lenses of normal compression factor about 0.50-0.75D.

Treatment:

Device: Orthokeratology

Orthokeratology with increased compression factor

Active Comparator group

Description:

Subjects wearing orthokeratology lenses of increased compression factor about 1.50-1.75D.

Treatment:

Device: Orthokeratology