Safety and ocular health with an orthokeratology lens in Chinese myopes: a retrospective, multicentre study.

CLINICAL RELEVANCE: The safety of orthokeratology needs to be regularly monitored. Retrospective studies of orthokeratology can provide safety data for real-world clinical settings.

BACKGROUND

This study aimed to evaluate the safety of an orthokeratology lens (Paragon CRT® 100 and Paragon CRT® Dual Axis [CRT-E], Paragon Vision Sciences, Inc. a CooperVision company; paflufocon D) among myopic Chinese children and adults.

METHODS

Patient records were reviewed for ocular adverse events at five clinical sites in China. Patient records meeting all of the following criteria were selected for data extraction: sphere refraction within -4.00 D (inclusive) and astigmatism within 1.50 D (inclusive) before wearing corneal refractive therapy (CRT) lenses, and wear of CRT lenses for over 335 days. Ocular adverse events are reported, by person, as number of events, incidence, and incidence rate.

RESULTS

In total, 2,793 patient records were screened, and 2,768 met the data-extraction criteria. Patients were aged 6 to 33 years; median age was 10 years (IQR: 9-12 years). Most patients (2,318) wore CRT lenses in both eyes, although 450 patients had monocular treatment. Lens wear totalled 3,269 patient-years, during which there were no serious ocular adverse events. There were 300 ocular adverse events among 241 patients (incidence of 8.7%); 282 events were mild, and 18 events were moderate. Device-related ocular adverse events occurred 175 times among 134 patients (4.8% incidence); 167 events were mild, and 8 events were moderate. The most common device-related events were corneal epithelial defects (108) - including corneal epithelial staining, abrasion, and epithelial roughness - and conjunctival hyperaemia (23), most of which self-resolved. The rate of device-related ocular adverse events was 5.4 per 100 patient-years (95% CI: 4.6-6.2).

CONCLUSION

The orthokeratology lenses are safe for overnight wear among Chinese myopes, as demonstrated by the low incidence and mild-to-moderate nature of ocular adverse events.