A 1-Year Prospective Clinical Trial of Menicon Z (tisilfocon A) Rigid Gas-Permeable Contact Lenses Worn on a 30-day Continuous Wear Schedule

Abstract

Continuous wear of the tisilfocon A (Menicon Z, Menicon Co., Ltd., Nagoya, Japan) RGP lens for up to 30 nights is a safe and equivalent alternative to 7-day (6-night) hydrogel wear.

Adverse Events and Discontinuations With Rigid and Soft Hyper Dk Contact Lenses Used for Continuous Wear

“…The likely reason for this discrepancy is that only experienced wearers were recruited into the FDA studies, whereas an even mix of experienced wearers and neophytes was used in our study. Certainly, when our data are reanalyzed for experienced wearers only, the rate of discontinuation for experienced rigid lens wearers (8.0%; 95% confidence interval [CI] 2.2% to 25.0%]) was similar to that reported by Gleason et al 11 (11.0%; CI 8.0% to 15.0%). For experienced soft lens wearers, 12.0% of subjects (CI 4.2% to 30.0%) were discontinued.…”

“…In two relevant multicenter studies, Gleason et al 10,11 fitted 317 subjects with lenses made from the Menicon tisifocon A material (in either the "Z" or the "Z-alpha" design) and McNally et al 12,13 fitted 658 subjects with the Focus Night & Day lens. Our study and the two FDA studies noted here were of 12 months' duration.…”

Corneal neovascularization

“…Published estimates 5,[9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] of the prevalence of lens-induced neovascularization are presented in Table 23.1. When considering the data presented in this table, it is important to bear in mind that there are significant differences between studies with respect to sample sizes, experimental protocols, patient characteristics and criteria chosen for considering a vascular response as being normal versus abnormal.…”

Is Corneal Refractive Therapy a New Modality Whose Time Has Come or Repackaged Orthokeratology Whose Time Has Passed?

“…25 It is estimated that 50 m changes in corneal thickness will affect intraocular pressure by 2.5 mmHg. Because CRT can reduce corneal epithelial thickness from 70 to 10 m, this can significantly affect accuracy of intraocular pressure measurements.…”