Retardation of Myopia in Orthokeratology (ROMIO)

The Hong Kong Polytechnic University

Status: Completed

Conditions: Myopia

Treatments: Device: orthokeratology lenses; Device: single-vision spectacle lenses

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00962208

H-ZG13

Details and patient eligibility

About

The primary aim of this study is to evaluate and compare the eyeball elongation in children wearing orthokeratology lenses and single-vision spectacles.

Full description

Prevalence of myopia is high in Asian countries like Hong Kong. Orthokeratology has shown potential in slowing myopic progression but the efficacy is yet to be confirmed by a randomized clinical trial (RCT). The current RCT aims at studying the efficacy of orthokeratology in retardation of myopic progression by comparing the eye growth in terms of axial length elongation in children wearing orthokeratology lenses (study group) and those wearing single-vision spectacles (control group).

Enrollment: 102 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Myopia (refractive sphere): > 0.50D and ≤ 4.00D
• Astigmatism: < ½ of myopia; with-the-rule astigmatism (axes 180 +/- 30) ≤1.25D; astigmatism of other axes ≤ 0.50D
• Spherical equivalent (SE): > 0.75D and ≤ 4.50D
• Anisometropia: ≤ 1.50D in both refractive sphere, refractive cylinder and SE
• Best corrected monocular visual acuity: equal to or better than 0.10 in logMAR scale in both eyes
• Willingness for randomization
• Willingness to wear contact lenses or spectacles on a daily basis
• Availability for follow-up for at least 2 years

Exclusion criteria

• Strabismus at distance or near
• Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex
• Prior experience with the use of rigid lenses (including orthokeratology)
• Prior experience with myopia control treatment (e.g. refractive therapy or progressive add spectacles)
• Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
• Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

102 participants in 2 patient groups

orthokeratology lenses

Experimental group

Description:

Children wearing orthokeratology at night for correcting of refractive error will be study group

Treatment:

Device: orthokeratology lenses

single-vision spectacle lenses

Other group

Description:

Children wearing single-vision spectacles in the daytime for correcting the refractive error will serve as control group

Treatment:

Device: single-vision spectacle lenses