PURPOSE:

The Arise Orthokeratology (Ortho-K) (oprifocon A) lens is indicated for overnight wear for the temporary reduction of myopic refractive error up to −5.00D and astigmatism up to 1.50D. For patients with corneal toricity, the use of toric posterior peripheral curves can aid in achieving a successful fit. This study aimed to evaluate the safety and effectiveness of the Arise Ortho-K lens with toric posterior peripheral curves. Here we present the primary effectiveness and safety outcomes from the study.

METHODS:

This single-treatment, multicenter, open-label study enrolled Ortho-K lens-naïve patients aged ≥12 years with spherical refractive error between plano and −5.00D, astigmatism ≤1.50D, and a corneal topography sagittal height differential between the principal meridians of ≥30μm at an 8mm chord diameter. All patients were required to wear the lenses for ≥8 hours overnight for 3 months, and attended follow-up visits at Day 1, Week 1, and Months 1, 2, and 3. The primary effectiveness outcome was the proportion of patients achieving an uncorrected distance visual acuity (UDVA) of 20/40 or better in both eyes at Month 3. The primary safety outcome was the rate of serious adverse events (SAEs).

RESULTS:

Seventy-six patients (152 eyes) were dispensed Arise Ortho-K lenses. Of those, 46 patients (92 eyes) completed the study (mean [SD] age, 29.6 [10.7] years; 63.2% female; 67.1% white, 14.5% Asian, 13.2% black or African American). The most common reason for discontinuation was voluntary withdrawal (31 eyes). The majority of discontinuations (any cause) occurred by Week 1 (16 patients, 32 eyes). Median (range) baseline high contrast distance visual acuity with habitual correction was 0.010 (−0.20, 0.60) logarithm of the minimum angle of resolution (LogMAR), median (range) manifest refractive spherical equivalent was −3.00 (−5.63, −0.38)D, median (range) sagittal height differential was 42.0 (30.0, 88.0)μm, and mean (SD) keratometry was 43.9 (1.4)D. Following 3 months of overnight lens wear, 93.3% (42/45) of patients achieved a monocular high-contrast UDVA of 20/40 (0.30 LogMAR) or better in both eyes (95% CI: 82.1%, 97.7%). The proportion of eyes with monocular high-contrast UDVA of 20/40 (0.30 LogMAR) or better at the Month 1, 2, and 3 follow-up visits was 94.4%, 91.1%, and 94.4%, respectively. No SAEs were reported. The most common device-related adverse event was corneal abrasion, which occurred in 8 eyes of 6 patients (all of which resolved during the study).

CONCLUSION:

In this study population, the Arise Ortho-K lens provided good unaided daytime visual acuity in most patients, from Day 1 to Month 3 of overnight wear, with no SAEs. Overall, the results of this study demonstrate the safety and effectiveness of the Arise Ortho-K lens design with toric posterior peripheral curves.