Protocol for Comparison of ocular biometry measurements in NOA and IOLMaster 500.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is to compare the ocular biometry measurements captured by Elisar NOA and IOLMaster 500 device. The measured values will be compared with the limits indicated in the protocol.
研究概览
简要总结
Elisar’s NOA (Novel Ophthalmic Analyzer) is a device that is capable of performing anatomical measurements of the eye for artificial IOL power calculation and performing imaging of retinal layers. NOA is a versatile device that performs both the functions of Ocular biometry and OCT measurements of Retina.
Normal and Cataract eyes will be diagnosed by the ophthalmologist based on the following tests
- Slit-lamp examination Presence of cataracts will be judged by an ophthalmologist and marked against the LOCS grading method. Also, to make sure that no other abnormal findings are present in the anterior segment of the eye.
- Fundus examination The presence of normal posterior segment and with normal cup-disc ratio will be defined by the ophthalmologist and the patient will be recruited under Normals and Cataract eyes.
The objective of this study is to evaluate the comparison of the ocular biometry measurements and the effectiveness of the Elisar NOA device against the existing device in the market (IOLMaster 500).
The study includes Cataract eyes of 200 and 75 eyes of Healthy Controls for comparison of the biometry measurements. To show the agreement between Elisar’s NOA and IOLMaster 500, bland-altman plots will be plotted against the measured values, and the values are expected to be within the indicative limits that are captured from the similar studies.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Visual acuity as tested within one week of the trial should be better than 6/18 will be selected for the study.
- •One eye of each patient should be selected by either randomly or the eye operated first.
- •Inclusion for Controls
- •Patients said to be clinically normal by ophthalmologist.
- •Inclusion for Cataract
- •Patients diagnosed with cataract graded using the LOCS grading method by ophthalmologist.
- •Eyes that are undergoing cataract surgery candidates in the clinic.
排除标准
- •Presence of keratoconus or suspect keratoconus, a previous diagnosis of dry eye, history of any corneal disease or trauma, any kind of ocular surgery, and use of contact lens past month.
- •Eyes with retinopathy or maculopathy, eyes with a history of corneal disease, pseudophakic eyes.
- •Patients with corneal pathology, previous refractive surgery or abnormalities in the anterior segment.
结局指标
主要结局
The primary endpoint of this study is to compare the ocular biometry measurements captured by Elisar NOA and IOLMaster 500 device. The measured values will be compared with the limits indicated in the protocol.
时间窗: 12 weeks
次要结局
- The secondary endpoint of this study is to compare the predicted refractive error for the calculated IOL power of each patient in both Elisar NOA and IOLMaster 500 where the difference in the error is not more than 1D.(12 weeks)
研究者
Dr S Soundari
Dr Agarwals Eye Hospital