PURPOSE:

When fitting orthokeratology (Ortho-K) lenses, corneal sagittal height differential (SHD) along the principal meridians where the landing zone is located is an important consideration. For patients with SHD ≥30μm, toric peripheral curves aid in achieving a successful fit. The Arise 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. This study aimed to evaluate the safety and effectiveness of the Arise Ortho-K lens with toric posterior peripheral curves. This analysis outlines the lens fit and stability results.

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 SHD between the principal meridians of ≥30μm at an 8mm chord diameter. 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. Lens fit (centration and movement) was assessed at the Dispensing and Day 1 visits. Stability measures included the proportion of eyes achieving refractive stability, eyes achieving stable keratometry readings, and eyes achieving stable uncorrected distance visual acuity (UDVA).

RESULTS:

Of 76 patients (152 eyes) dispensed Arise Ortho-K lenses, 46 (92 eyes) completed the study. The majority of discontinuations occurred by Week 1, with the most common reason for discontinuation being voluntary withdrawal. Monocular high-contrast UDVA of 20/40 or better in both eyes was achieved by 93% (42/45) of patients at the Month 3 follow-up visit. Acceptable lens fit was reported for 96% of eyes and patients at the Dispensing Visit. Following the first night of overnight wear, acceptable lens fit assessments were reported for 96% of eyes and 94% of patients. There were no reports of poor lens fit assessments. At every follow-up visit, ≥80% of patients achieved adequate corneal centration in both eyes; adequate centration remained consistent throughout visits. Lens movement was adequate for 94% of eyes and 93% of patients at the Dispensing Visit and for 87% of eyes and 85% of patients at the Day 1 follow-up visit. At either of two consecutive visits (Month 1 and Month 2, or Month 2 and Month 3), the proportion of eyes achieving refractive, keratometry, and UDVA stability was 84%, 87%, and 82%, respectively.

CONCLUSION:

In this study, the Arise Ortho-K lens with toric peripheral curves provided acceptable fit and adequate centration in almost all patients from the first night of overnight wear, and refractive, keratometry, and UDVA stability were achieved in a high proportion of patients. This work further supports that Ortho-K lenses with toric peripheral curves offer a valuable and effective option for patients with corneal toricity.