NCT05984290

Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens

Study to Evaluate Safety and Effectiveness of the Boston Orthokeratology (Oprifocon A) Shaping Lens in the Arise Orthokeratology Lens Design With Non-spherical Posterior Peripheral Curves

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this orthokeratology study is to evaluate the safety and effectiveness of the Arise Orthokeratology Lens with non-spherical posterior peripheral curves

Detailed description

The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry orthokeratology design that includes a base curve/treatment curve, a reverse curve, alignment curves and peripheral curves. The base curve is used to only flatten the cornea and is not considered a fitting curve. The parameters of the Arise Orthokeratology Lens are controlled to be within the bounds determined by the spherical posterior curves of other lens designs prescribed for the Bausch + Lomb Vision Shaping Treatment. The term peripheral curves excludes the base curve and includes the zones defined as the reverse curve, alignment curves and peripheral curves. Peripheral curves are designed to help control centration of the lens. When there are elevation differences between the flat and steep meridians on the cornea (e.g., corneal toricity), spherical peripheral curves, including the reverse curve, alignment curves and peripheral curves, may not align completely to the cornea and can result in a lens with sub-optimal centration. Aspheric curves and toric (e.g., dual axis) peripheral curves on reverse geometry lenses for overnight orthokeratology have been available in the US market for more than 10 years for fitting lenses. The intent of the Arise Orthokeratology Lens is to provide a stable and centered lens that helps ensure the treatment zone of the lens is well positioned in relation to the pupil and is shaping the central portion of the cornea for optimal results.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	orthokeratology lens	Each subject will wear the study lenses in both eyes overnight for approximately 3 months.

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2023-08-09
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study