Protocol for Repeatability & Reproducibility of Elisars NOA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study is to compare the repeatability and reproducibility of the biometry and OCT measurements in Elisar NOA by calculating the Standard deviation(SD) and limits for the repeated measurement and compare with the indicative limits.
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 an eye for artificial IOL power calculation and perform imaging of retinal layers. NOA is a versatile device that performs both the functions of Ocular biometry and OCT measurements of Retina.
The gold standard for a device in clinical diagnosis is the ability of the device to produce repeatable and reproducible accurate results. Ocular biometry is the most important procedure in Cataract surgery as the biometry measurements are used to calculate the accurate Intraocular Lens power. OCT measurements of retinal layers aid in the diagnosis and treatment of different diseases. Thus it is important to produce a device that produces repeatable accurate measurements.
The objective is to evaluate the repeatability & reproducibility of biometry and OCT measurements in Elisar’s NOA that are acceptable and precise. This study is done in 2 stages, where stage 1 is for biometry measurement and stage 2 is for OCT measurements. Each stage has 3 phases that are Inter-device phase, the Intra-operator phase, Inter-operator phase. The result of this study is to match the repeatability and reproducibility measurement with the indicative limits that are considered from similar studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •For Stage 1 Study Controls
- •Patients said to be clinically normal by an ophthalmologist.
- •Patients diagnosed with cataracts that are graded using the LOCS grading method by an ophthalmologist.
- •Eyes that are undergoing cataract surgery candidates in the clinic.
- •For Stage 2 Study Controls
- •All subjects had no history of any ocular diseases, a fundus appearance should be normal.
- •A definitive diagnosis of glaucoma, defined as glaucomatous visual field loss with an accompanying optic nerve abnormality typical of glaucoma.
- •The glaucoma needed to be stable, and the patient required at least two reliable SITA Standard 24-2 HVF examinations.
排除标准
- •For Stage 1 Study
- •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.
- •For Stage 2 Study Normal
- •a history of glaucoma or any other ocular disease or systemic diseases such as diabetes and images were also excluded if they had unusable OCT scans due to poor signal strength (less than 6) or algorithm failure.
- •any history of previous retinal disease such as macular degeneration or optic nerve disease, including non-glaucomatous optic neuropathy.
- •Both normal and glaucoma images were also excluded if they had unusable OCT scans due to poor signal strength (less than 6) or algorithm failure, in which the boundaries for the RNFL layer were not delineated correctly.
结局指标
主要结局
The primary endpoint of this study is to compare the repeatability and reproducibility of the biometry and OCT measurements in Elisar NOA by calculating the Standard deviation(SD) and limits for the repeated measurement and compare with the indicative limits.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Dr S Soundari
Dr Agarwals Eye Hospital