NCT06555289招募中不适用
Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery
Juliette Eye Institute Research Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Binocular corrected distance visual acuity (logMAR)
研究概览
简要总结
This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, 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
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
- •Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
- •Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.
- •Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3
- •Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.
排除标准
- •Any ocular comorbidity that might hamper postoperative visual acuity:
- •Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
- •Moderate or severe dry eyes that can't be relieved after treatment.
- •History of or current anterior and posterior inflammation of any etiology.
- •Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
- •Glaucoma of any kind.
- •Pregnancy or lactation.
- •Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
- •Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
- •Apple Kappa/chord mu ≥ 0.
- •Higher order corneal aberrations at pupil diameter of 4mm: > 0.6 total RMS, > 0.3 coma, > 0.3 trefoil (to exclude irregular corneas)
- •Any patient requiring a limbal relaxing incision.
- •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.
结局指标
主要结局
Binocular corrected distance visual acuity (logMAR)
时间窗: 3 months postoperative
次要结局
- Binocular distance corrected visual acuity at intermediate (logMAR)(3 months postoperative)
- Binocular unccorrected visual acuity at distance (logMAR)(3 months postoperative)
- Binocular distance corrected visual acuity at near (logMAR)(3 months postoperative)
- Binocular unccorrected visual acuity at intermediate (logMAR)(3 months postoperative)
- Binocular unccorrected visual acuity at near (logMAR)(3 months postoperative)
研究者
研究点 (1)
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