Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients Undergoing a Refractive Lens Exchange With Bilateral Implantation Odyssey Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Binocular Photopic Visual Acuity
研究概览
简要总结
This study is a single center, ambispective study of visual outcomes after successful bilateral implantation of the Odyssey IOL. Subjects will be assessed at least 2 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS questionnaire, as well as measurement of visual acuities at distance, intermediate, and near, monocular (right eye) and binocular defocus curve, and refractive outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will include 40 patients aged 40 years and older who have a measurable Potential Acuity Meter (PAM) of 20/20 electing to undergo bilateral refractive lensectomy surgery with IOL implantation.
排除标准
- •Patients with significant ocular comorbidities (e.g., macular degeneration, glaucoma) or prior intraocular surgery will be excluded.
结局指标
主要结局
Binocular Photopic Visual Acuity
时间窗: 2 months posoperatively
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Monocular Photopic Visual Acuity
时间窗: 2 months posoperatively
Measured at distance (6m), intermediate at 66cm, and near visual acuity at 40cm and 33cm.
Monocular Defocus Curve (right eye only)
时间窗: 2 months posoperatively
Binocular Defocus Curve
时间窗: 2 months posoperatively
次要结局
- Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire(2 months posoperatively)