Development of a Medical Device Based on Ultrasounds for Objective Cataract Characterization and Optimal Phacoemulsification Energy Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Presence of Cataract
研究概览
简要总结
This study aims to assess the performance of an ultrasonic system for automatic classification of cataract type and severity, as well as the estimation of the optimal phacoemulsification energy. Ultrasonic signals from the lens will be acquired with the Experimental Medical Device (ESUS) in participants with cataract, and in healthy subjects (control).
The proposed technique may represent an important advance in cataract treatment. The quantitative and automatic classification of cataract type and severity, and the estimation of the optimal phacoemulsification energy is may represent a valuable tool for surgical planning, reducing complications associated to excessive levels of phacoemulsification energy, as well as the times spent on surgeries. This device may be relevant not only for patients, but also for public health systems, reducing waiting lists and associated costs.
详细描述
This is a prospective, pivotal, non-blinded study. Fifty (50) participants will be recruited at the Coimbra Surgical Center of Portugal. The study will be conducted on subjects with age-related cataract, and on healthy subjects as control group. Since this is a pilot study, no sample size estimation has been implemented. The statistical power will be determined at the end of the study. Only per-protocol participants will be considered on statistical analysis.
Procedures involved. The ultrasonic system (Experimental Medical Device - ESUS) works in A-scan mode, with an acoustic working frequency of 20 MHz. From the ultrasonic signals backscattered from the lenses, acoustic parameters will be extracted, and used for automatic algorithms implementation. This study will be implemented once.
Slit lamp with LOCS III classification will be used as comparator. Contrast sensitivity test results will be used for incipient cataract detection, where slit lamp may present some limitations. Optical coherence tomography and specular microscopy will help on detecting postoperative complications; other complications identified by the physician will be also considered. Surgical parameters as phacoemulsification energy and surgical time will help on phacoemulsification energy evaluation.
Safety assessment. The system uses an ophthalmic probe. There are not anticipated adverse events related to the procedures involved in the use of the ultrasonic system, or any other procedure in the protocol. The safety conditions will be monitored through the occurrence of unanticipated adverse events or serious adverse events. If these situations occur, the event will be reported to the competent authorities (in agreement with the current regulation) and the corrective actions will be implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cataract group:
- •Patients with age-related cataract;
- •Indication of phacoemulsification surgery
- •Control group:
- •Patients without cataract
排除标准
- •Presence of any other ophthalmological condition or systemic disease that could affect the results
研究组 & 干预措施
Cataract
Participants with diverse types and severities of cataract, that should realize phacoemulsification surgery
干预措施: Eye Scan Ultrasound System (ESUS) (Device)
Control
Participants on which the presence of cataract have been excluded
干预措施: Eye Scan Ultrasound System (ESUS) (Device)
结局指标
主要结局
Presence of Cataract
时间窗: baseline
Presence of cataract obtained with the Experimental Medical Device (ESUS)
次要结局
- Cataract classification(baseline)
- Cataract hardness(before the intervention/procedure/surgery)
- Phacoemulsification energy(immediately after the intervention/procedure/surgery)
研究者
Jaime Batista Santos
Investigator Responsible
University of Coimbra