Barr Joseph T, Pall Brian, Szczotka Loretta B, Mitchell G Lynn, Gleason William
The Ohio State University, College of Optometry, Columbus, OH 43218-2342, USA.
Eye Contact Lens. 2003 Jan;29(1):14-6. doi: 10.1097/00140068-200301000-00004.
This evaluation was conducted as part of a protocol entitled Evaluation of the Menicon Z Rigid Gas Permeable Contact Lens for up to 30 Days Extended Wear. The purpose of the protocol was to compare corneal endothelial morphology changes after wearing rigid gas-permeable (RGP) Menicon Z contact lenses, continuously for up to 30 days, with ACUVUE (Johnson & Johnson Vision Care) hydrogel contact lenses, worn for up to 6 nights of extended wear.
Sixty patients, who were adapted to RGP daily wear and soft contact lens daily wear, were recruited at two study sites. The thirty subjects who wore RGP daily wear lenses were fitted with the Menicon Z (tisilfocon A, oxygen permeablility [Dk] = 163) RGP contact lens comprised the test group. The control group subjects (n = 30 former users of daily wear soft contact lenses) were fitted with ACUVUE (etafilcon A, Dk = 28) hydrogel contact lenses. After a 2-week adaptation period of daily wear, subjects began extended wear. Endothelial imaging was performed at the two study sites in this multicenter study (University Hospitals of Cleveland/Case Western Reserve University Department of Ophthalmology [CWRU] and The Ohio State University [OSU]). The hydrogel lens group was instructed to wear their lenses for 7 days and 6 nights before discarding the lenses and to sleep with no lenses on the seventh night. The RGP group was permitted to wear the lenses for up to 30 days and 29 consecutive nights before removing the lenses for cleaning and overnight soaking.
CWRU had 24 patients (12 soft contact lens and 12 rigid contact lens) and OSU had 21 patients (12 soft contact lens and 9 rigid contact lens) who completed the study and were included in the analyses. Patients who were withdrawn from the study at CWRU included one RGP patient dropped out because of pregnancy; one RGP patient developed vascularized limbal keratitis and discomfort; one could not be fitted with a bitoric RGP; two soft lens patients moved from the area, and one dropped out because of dry eyes. At OSU, four patients dropped out due to discomfort (two in each lens type);one moved from the study area; one decided not to participate soon after the consent visit; one had worries of reduced vision at 6 months; one subject's attitude changed prior to the 6 month visit; and one subject was withdrawn for reasons of poor study schedule compliance.
The Menicon Z lens wearers in this study did not show significant endothelial cell morphology changes after 1 year of nearly continuous contact lens wear. This finding is particularly important considering the RGP wearers in this study were older by a average of 10 years (mean age approximately 40) and had worn their contact lenses an average of almost 10 years longer than the soft contact lens wearers.
本次评估是一项名为“美尼康Z型硬性透气性角膜接触镜长达30天连续佩戴评估”方案的一部分。该方案的目的是比较连续佩戴硬性透气性（RGP）美尼康Z型角膜接触镜长达30天与佩戴ACUVUE（强生视力健公司）水凝胶角膜接触镜长达6晚后角膜内皮形态的变化。
在两个研究地点招募了60名适应RGP日戴和软性角膜接触镜日戴的患者。佩戴RGP日戴镜片的30名受试者佩戴美尼康Z（硅水凝胶A，透氧系数[Dk]=163）RGP角膜接触镜，组成试验组。对照组受试者（n=30名既往日戴软性角膜接触镜使用者）佩戴ACUVUE（依他氟康A，Dk=28）水凝胶角膜接触镜。经过为期2周的日戴适应期后，受试者开始连续佩戴。在这项多中心研究的两个研究地点（克利夫兰大学医院/凯斯西储大学眼科系[CWRU]和俄亥俄州立大学[OSU]）进行内皮成像。水凝胶镜片组被指示在丢弃镜片前佩戴镜片7天6晚，并在第七晚不戴镜片睡觉。RGP组被允许在取下镜片进行清洁和过夜浸泡前连续佩戴镜片长达30天29晚。
CWRU有24名患者（12名软性角膜接触镜患者和12名硬性角膜接触镜患者），OSU有21名患者（
