Ignite Creation Date:
2024-05-06 @ 2:22 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04295707
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2020-02-29
Brief Title:
Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Accrued Effect of Orthokeratology for Myopia Control in Children and the Effectiveness of Myopia Control Using an Innovative Orthokeratology Modality Experiment 1 Effect in Existing Ortho-k Wearers
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_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:
MR1
Brief Summary:
The two-year prospective study aims at investigating the benefits of frequent replacement monthly orthokeratology lenses in myopia control in terms of effectiveness in control and prevention of ocular complications The secondary objective will be investigating the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit
Detailed Description:
This is a two-year randomized trial Existing orthokeratology lens wearers aged 8-13 years who have completed a 2-year myopia control using orthokeratology will be recruited and monitored for another two years Eligible subjects will be randomly assigned to monthly or yearly replacement modality Axial elongation and ocular conditions will be compared between the monthly and yearly replacement groups
Subjects on monthly replacement lenses will be randomly assigned to normal cleaning and intensive cleaning groups Subjects in normal cleaning group will be provided with complimentary contact lenses solutions for daily cleaning and disinfection In addition to the daily procedures for lens case subjects in the intensive cleaning group will be required to perform weekly protein removal All subjects on yearly replacement lenses will be required to performed intensive cleaning such that they will follow normal daily cleaning and disinfection as well as weekly protein removal
Subjects on monthly replacement lenses will be randomly assigned to normal cleaning and intensive cleaning groups Subjects in normal cleaning group will be provided with complimentary contact lenses solutions for daily cleaning and disinfection In addition to the daily procedures for lens case subjects in the intensive cleaning group will be required to perform weekly protein removal All subjects on yearly replacement lenses will be required to performed intensive cleaning such that they will follow normal daily cleaning and disinfection as well as weekly protein removal
Study Oversight
Has Oversight DMC:
None
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?:
None