NCT04806763

Myopia Control With Orthokeratology Contact Lenses in Spain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Menicon Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.

Detailed description

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.

Conditions

• Myopia, Progressive
• Children, Only
• Contact Lens Complication
• Perception, Self
• Axial Myopia

Interventions

Type	Name	Description
DEVICE	Menicon Z Night	To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children
DEVICE	Control	Distance, single-vision glasses were used as control

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2021-03-19
• Last updated: 2021-03-26