NCT05518227终止不适用
Patient Satisfaction and Visual Outcomes After Bilateral PanOptix Implantation in Patients With Previous Multifocal Contact Lens
Vivid Laser Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Satisfaction questionnaire
研究概览
简要总结
To evaluate spectacle independence and patient satisfaction and visual outcomes after bilateral PanOptix implantation in patients with previous multifocal contact lens experience.
详细描述
This study is a single-arm unmasked clinical evaluation study of patient satisfaction after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 week and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible for the study if they meet the following criteria:
- •Note: Ocular criteria must be met in both eyes.
- •Adult cataract patients undergoing uncomplicated cataract surgery with Clareon PanOptix IOL implantation (non-toric/toric).
- •Visually significant cataracts bilaterally.
- •History of successful soft multifocal contact lens use in the past (within ≤ last 5 years).
- •Healthy ocular exam.
- •Gender: Males and Females.
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visits and other study procedures.
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Previous monovision patients.
- •Ocular comorbidity that might hamper post operative visual acuity (Uveitis, Keratoconus, Retinopathies, Glaucoma).
- •Previous ocular or refractive surgery.
- •Expected monocular post-op distance VA worse than 20/25 (Snellen) in either eye.
- •Refractive lens exchange.
- •Angle kappa measurement in a single eye over 0.6 mm.
- •Irregular corneal astigmatism or ectasia.
- •Difficulties comprehending written or spoken English language.
- •Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- •Severe/uncontrolled Ocular surface disease/Dry Eye Disease.
- •Intraoperative complications during procedure.
- •Visual expectations exceed outcomes.
- •Strabismus (with or without amblyopia).
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- •Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
结局指标
主要结局
Satisfaction questionnaire
时间窗: 3 months postoperative
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.
次要结局
- Binocular uncorrected distance visual acuity (6m)(3 months postoperative)
- Binocular uncorrected intermediate visual acuity (60 cm)(3 months postoperative)
- Binocular distance corrected intermediate visual acuity (40 cm)(3 months postoperative)
- Manifest refraction(3 months postoperative)
- Spectacle independence(3 months postoperative)
- Binocular uncorrected near visual acuity (40 cm)(3 months postoperative)
- Binocular corrected distance visual acuity (6m)(3 months postoperative)
- Binocular distance corrected intermediate visual acuity (60 cm)(3 months postoperative)
研究者
研究点 (1)
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