on-dispensing clinical evaluation of customised OneFit MED scleral contact lenses

CooperVision International Limited0 个研究点目标入组 30 人开始时间: 2022年7月7日最近更新: 2023年5月8日

适应症

试验速览

暂无简介。

•1. 40 or more years of age
•2. Have read and understood the Participant Information Sheet in English
•3. Have read, signed and dated the Informed Consent
•4. Current multifocal contact lens wearer
•5. Spectacle refraction:
•5.1. Distance: Sphere: -6.00D to + 4.00DS
•5.2. Astigmatism: -0.00DC to -1.50DC in each eye
•5.3. Near Addition: +0.75D to +2.50D
•6. Best corrected visual acuity of at least 20/25 in each eye
•7. Have normal eyes with the exception of the need for visual correction
•8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

•1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
•2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator
•3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
•4. Any moderate or severe ocular condition observed during the slit lamp examination at the enrolment visit
•5. History of herpetic keratitis, ocular surgery or irregular cornea
•6. Known pregnancy or lactation during the study period
•7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

发起方