NCT04295707

Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Myopic Progression

Interventions

Type	Name	Description
DEVICE	orthokeratology	Nightly wear of orthokeratology lenses to correct vision in the daytime
DEVICE	Menicon Progent A+B	Menicon Progent A+B is a commercially available protein remover for rigid lenses. It has received FDA clearance and been launched in Hong Kong for over a decade. The product contains two separate sterile solutions, one with sodium hypochlorite and the other with potassium bromide. By mixing the two solutions in a special vial, it can clean and remove protein deposits on the lenses. Parents of subjects assigned to use weekly protein remover will be required to soak the cleansed lenses in the solution mixture for not more than 30 mins every week. All lenses must be rinsed thoroughly with saline and cleansed with daily cleaner again before daily disinfection.

Timeline

• Start date: 2020-03-11
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2020-03-04
• Last updated: 2022-07-19

Locations

1 site across 1 country: Hong Kong