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临床试验/NCT06550375
NCT06550375已完成不适用

Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses

Mann Eye Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Visual Acuity at Near (40cm) logMAR

研究概览

简要总结

This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.

排除标准

  • Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
  • < 2 weeks post YAG capsulotomy.
  • Best corrected distance visual acuity worse than 20/25.

结局指标

主要结局

Visual Acuity at Near (40cm) logMAR

时间窗: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Visual Acuity at Near (33cm) logMAR

时间窗: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Visual Acuity at Distance (6m) logMAR

时间窗: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

Visual Acuity at Intermediate (66cm) logMAR

时间窗: 3 months postoperative

Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected

次要结局

  • Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare(3 months postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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