Clinical Evaluation of a Novel Intraoperative Guidance System for Accurate Toric IOL Positioning in Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy (measured in degrees of arc) using the Cassini Guidance system for calculated alignment axis for toric IOL implantation.
研究概览
简要总结
This study aims to assess the accuracy of toric intraocular lens (IOL) alignment axes as calculated and displayed by a novel digital guidance system. In addition, it evaluates the time required to initiate surgical guidance and postoperative refractive astigmatism following toric IOL implantation.
This single-surgeon, single-site, prospective, non-invasive observational study evaluated the accuracy of toric IOL alignment axes calculated and displayed by the digital guidance system (Cassini Technologies, B.V.) in 100 eyes. The intraoperatively calculated alignment axes were compared to preoperative measurements to assess their accuracy (in degrees). Postoperative outcomes, including residual refractive astigmatism (diopters) and visual acuity (Snellen), were recorded at 1 month postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing uncomplicated cataract surgery with toric IOL implantation,
- •Eyes implanted with a toric IOL.
排除标准
- •Ocular comorbidity likely to impair postoperative visual acuities, or
- •History of ocular trauma or zonular instability, or
- •Previous refractive surgery, or
- •Irregular corneal astigmatism or keratoconus, or
- •Patients with physical or intellectual disabilities that may prevent reliable fixation or comprehension (e.g. Down's Syndrome, Parkinson's Disease), or
- •Patients with unreliable biometry measurements, or
- •Severe dry eye disease or ocular surface disease.
研究组 & 干预措施
Surgical guidance for Toric IOL alignment intraoperatively
Interventional
干预措施: Cassini Guidance (Device)
结局指标
主要结局
Accuracy (measured in degrees of arc) using the Cassini Guidance system for calculated alignment axis for toric IOL implantation.
时间窗: Total completion up to 12 months
Primary Endpoint: 1\. Accuracy of the calculated alignment axis (degrees of arc = angular degrees) * Definition: The angular difference between the alignment axis for toric IOLs as determined with the CGS and the intended alignment axis as determined with the Cassini Ambient. * Thresholds of interest: ≤3°, ≤5°, ≤10°, \>10°. * Justification: Misalignment greater than 10° results in a clinically significant loss of toric correction (approximately 33%) (Quesada et al., 2022; Hu, 2023), making this a meaningful accuracy benchmark.
次要结局
- Time efficiency (measured in seconds) of the Cassini Guidance System in eyes undergoing cataract surgery with toric IOL implantation.(Total completion up to 12 months)