NCT03881358

Orthokeratology for High Myopia (OHM) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Accepted

Summary

This project aims to investigate/examine high myopic subjects on full correction ortho-k (using Topaz ortho-k lenses for high myopia) compared to subjects undergoing partial reduction ortho-k and their relationship with myopia and myopic progression.

Detailed description

For many years, commercially-available ortho-k lenses aim to reduce low - moderate myopia. Attempts to use these lenses for reduction of high myopia have been shown to give rise to complications such as corneal staining and lens decentration. Thus, practitioners may choose a more conservative way for high myopic children, that is, offering partial reduction ortho-k. Partial reduction ortho-k is target for 4.00-5.00D reduction and the residual refractive errors will be corrected with single vision spectacles to allow good visual acuity in the daytime. Partial reduction ortho-k has been shown to slow axial elongation in high myopic children, however, the main disadvantage is that the children have to wear spectacles in the daytime to correct residual refraction. Euclid has recently designed a new lens, Euclid's Topaz, for high myopic children. It is currently commercially available to correct myopia for up to 10 D. However, evidence of its effectiveness for visual correction and slowing AL growth is lacking. While numerous studies have shown that orthokeratology is an effective clinical treatment to slow axial eye growth in children, the exact mechanism underlying this reduction in myopia progression associated with orthokeratology remains unclear.

Conditions

• Myopia
• High Myopia

Interventions

Type	Name	Description
DEVICE	ortho-k lenses and thinner spectacles	Conventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time
DEVICE	newly designed ortho-k lenses	Newly designed (Topaz) ortho-k lenses for high myopia (target for full correction)

Timeline

• Start date: 2018-08-04
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2019-03-19
• Last updated: 2021-02-16

Locations

1 site across 1 country: Hong Kong