ISRCTN96782461
已完成
未知
Visual performance and visual satisfaction measurement with multifocal contact lens combinations
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Presbyopia
- 发起方
- CooperVision Inc.
- 入组人数
- 100
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •There are no requirements as to participant race, gender or occupation.
- •In order to be enrolled, each participant shall meet the following criteria:
- •1\. At least 40 years old
- •2\. Have read and understood the Participant Information Sheet
- •3\. Have read, signed and dated the Informed Consent
- •4\. Current spectacle or soft contact lens wearer
- •5\. Spectacle refraction:
- •Distance: Sphere: \-6\.00D to \+4\.00D; Astigmatism: 0\.00D to \-0\.75D
- •Near Addition: Group 1 (Phase 1\) \- \+1\.00 to \+1\.50D; Group 2 (Phase 2\) – Subgroup A \+1\.75 to \+2\.00D; Subgroup B \+2\.25 to \+2\.50D
- •6\. Best corrected visual acuity in each eye of at least 20/25
排除标准
- •To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
- •The following are specific criteria that exclude a candidate from enrolment in this study:
- •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 contact 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
- •8\. Participation in any clinical trial within 30 days of the enrolment visit
结局指标
主要结局
未指定
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