Correlation of Pupillary Diameter Change With Age and Anterior Chamber Depth After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Anterior Chamber Depht
研究概览
简要总结
PURPOSE: To assess the correlation between the change in pupil diameter, age and depth of the anterior chamber after 3 months of cataract surgery both in photopic and mesopic conditions. And study the changes of the pupillary diameter at 3 months after surgery in the two light conditions
详细描述
Healthy patients who are going to be operated on for cataracts are expected to take part in the study. If during the clinical study the minimum number of patients established in the protocol is exceeded, new samples will continue to be registered until the end of the established period.
The sample selection mechanism is by consecutive recruitment during the study period (in order of arrival at the medical office). Patients are operated bilaterally in a period not exceeding 15 days and it will get the variables of both eyes. A simple random sampling will be used for the choice of single eye data per patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Both sexes with age equal to or greater than 45 years
- •Diagnosed cataract N1, C1, P1 or worse in some eye.
- •Patients who will be operated on both eyes.
- •Patients who have not been diagnosed with diabetes mellitus.
- •Patients who have given their informed consent to take part in the study.
排除标准
- •Age under 45 years.
- •Patients with anisocoria, neurological disorders, diagnosed with diabetes mellitus, glaucoma or another eye disease.
- •Patients with complications during and after cataract surgery.
结局指标
主要结局
Anterior Chamber Depht
时间窗: Preoperatively
Anterior chamber depth was obtained with Pentacam® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
Pupil diameter
时间窗: Preoperatively and 3-months postoperatively
It took measurements of pupil diameter in mesopic and photopic conditions using pupillometer software of the Topolyzer Vario (Wavelight Laser Technologie AG).
Age
时间窗: Preoperatively
It took the patient's age at the time of surgery
次要结局
未报告次要终点
研究者
Enrique Ordiñaga-Monreal, OD, MSc
Clinical Optometrist
Clinica Oftalmologica TACIR