NCT05733884

Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

Summary

A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.

Conditions

• Soft Contact Lens

Interventions

Type	Name	Description
OTHER	soft contact lens	soft contact lens

Timeline

• Start date: 2020-12-09
• Primary completion: 2022-05-04
• Completion: 2022-05-04
• First posted: 2023-02-17
• Last updated: 2023-02-21

Locations

1 site across 1 country: Taiwan