Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT03881358
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2019-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orthokeratology for High Myopia (OHM) Study
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
Orthokeratology for High Myopia (OHM) Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: