Abstract
Purpose :
To evaluate overnight ortho-k lens wear (paflufocon D, Paragon CRT Dual Axis® [CRT-E], CooperVision Specialty EyeCare) in regard to the 12-month incidence of device-related ocular adverse events (OAEs). Additionally, the study evaluated visual acuity, refraction, and lens conditions.
Methods :
In this single-arm clinical trial, subjects were eligible for enrollment if both eyes had a myopic refractive error of -0.50 to -4.00 DS, astigmatism up to -1.50 DC, and no corneal abnormality. At baseline and 1-day, 1-week, 2-week and 1-, 3-, 6-, 9- and 12-month follow-up visits, investigators assessed ocular health, uncorrected distance visual acuity (UCDA), and manifest refraction spherical equivalent (MRSE), and they examined lenses for breakages, protein deposition, and scratches.
Results :
Four sites in China enrolled 177 subjects (97 females, 80 males) aged 8 to 43 years (median: 11 years) with a mean spherical refraction of -2.51 DS and mean astigmatism of -0.49 DC. In total, 147 patients (83%) wore the lens in both eyes, and 30 patients (17%) wore the lens in one eye (Paragon CRT 100 was worn in the other eye). There were no serious or significant OAEs. A total of 21 OAEs were deemed likely to be device-related; these OAEs occurred among 15 subjects – an incidence of 8.5%. The device-related OAEs were: corneal epithelial defects (including staining, abrasions, roughness, and turbidity; 14 cases, 13 subjects), chronic conjunctivitis (6 cases, 6 subjects), and one case of ocular dryness. All OAEs were mild and resolved, i.e., tolerable for the subjects without affecting the ortho-k treatment, not requiring special treatment, and having no long-term effect on the ocular health of the subjects. Lens breakages, anterior surface protein deposition, posterior surface protein deposition, and scratches were observed at 0.03%, 1.6%, 1.0%, and 4.5% of assessments (3,194), respectively. Deposition was negligible in 80 cases (99%) and mild in one case (1%). Scratches were negligible in 127 cases (89%), mild in 12 (8%), and moderate in four (3%). Mean UCDA and MRSE were significantly improved compared to baseline values at all follow-up visits (P<0.05).
Conclusions :
Ortho-k lens wear is effective in correcting myopia and is safe for overnight wear among myopic Chinese children and adults, as demonstrated by the low incidence and mild nature of device-related ocular adverse events.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.