N/A N=102 Randomized Single-blind Treatment

Retardation of Myopia in Orthokeratology

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT00962208 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Sep 2013

Primary outcome: Primary: Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study — 0.36; 0.63 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: orthokeratology lenses (Device); single-vision spectacle lenses (Device)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: The Hong Kong Polytechnic University
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study	0.36; 0.63	—
SECONDARY Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups	—	—
SECONDARY Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear	—	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Myopia (refractive sphere): > 0.50D and ≤ 4.00D
Astigmatism: 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00962208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.