Is the Occuity Pachymeter Non Inferior in it's Measurement of Central Corneal Thickness Compared to the Ultrasound Pachymeter, Lenstar and Pentacam.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine whether the Occuity PM1 device is non-inferior in measuring central corneal thickness when compared to ultrasound pachymetry, the Lenstar and the Pentacam.
研究概览
简要总结
To determine whether the Occuity PM1 device is non-inferior in measuring central corneal thickness when compared to ultrasound pachymetry, the Lenstar and the Pentacam.
The Investigation aims to assess long-term safety of the Occuity PM1 device when used under the conditions and for the purposes intended, to ensure it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons.
The central corneal thickness measurements taken by the three devices: Occuity PM1, the ultrasound pachymeter and Lenstar. Demonstrating that the Occuity PM1 Pachymeter is not inferior to the LenStar in terms of equivalency to a 95% confidence level using the Bland Altmen equation/approach based on +/-20micron equivalency.
The investigators would like to measure the thickness of the cornea, which is the clear window at the front of the eye. A corneal thickness measurement is important for several reasons. The measurement can tell an eye care professional if the cornea is swollen, which may mean the particiapnt have an increase in fluid within the cornea. Also, assessing corneal thickness can help in the diagnosis of glaucoma and the measurement is important if the participant is going to have eye surgery.
The instruments that are currently in use are usually very large and quite expensive and therefore not ideal for use as part of routine eye care. Some instruments require contact with the surface of the eye, which may be uncomfortable.
Occuity Ltd. is a medical device company based in Reading, which has been investigating this. They have developed a new instrument (called the 'PM1 Pachymeter') for measuring the thickness of the cornea. The instrument shines a harmless low power beam into the eye and then measures the light reflected back from the eye in order to check the thickness of the cornea. The low power beam is not a visible light and so the participant will not be able to see it. s study will assess how closely the eye measurements taken from the new PM1 Pachymeter matches eye measurements taken from two other devices that are currently on the market. The goal is to provide a non-contact, hand-held meter that is fast and easy to use without the need to contact the eye.
详细描述
The cornea is a thin, transparent structure at the front of the eye; its surface, as well as the overlying tear film, is responsible for the majority of the eye's refractive power.
Accurate and precise measurement of corneal thickness is important in the diagnosis and management of many ocular diseases. In particular, the central corneal thickness (CCT) measurement is a key parameter to consider when planning for procedures such as refractive surgery, and in the diagnosis of glaucoma.
Refractive error is the leading cause of reversible visual impairment worldwide; it is therefore unsurprising corrective refractive surgery is one of the most widely performed procedures globally. In the United Kingdom, the most frequently performed refractive surgery are laser assisted surgical procedures, such as laser assisted in situ keratomileusis (LASIK), Laser epithelial keratomileusis (LASEK), and Photorefractive Keratectomy (PRK). All of these techniques involve ablating the cornea with a laser to achieve a specific shape. Having an accurate measurement of corneal thickness is therefore of utmost importance in the planning stages, as excessive ablation of the cornea can lead to corneal ectasia, a significant complication of refractive surgery .
Glaucoma is a progressive disease which causes irreversible vision loss, and with ever aging populations, it is now one of the leading causes of irreversible blindness worldwide. Although it is considered to be multifactorial in aetiology, with both genetic and acquired factors contributing to its development and progressions, it is still widely accepted that the intraocular pressure (IOP) is the only modifiable factor in its management to prevent or slow further visual loss. (5).
IOP measurement is typically done in hospital clinics using a Goldmann applanation tonometer. The pressure reading is affected by the corneal thickness - a thick cornea will give a falsely elevated IOP reading, which may result in a patient with healthy eyes being commenced on unnecessary treatment, while conversely a thin cornea may give a falsely low pressure reading, which can result in patients with glaucoma not being started on sight-saving treatment. It has been estimated that a 10% increase in CCT can result in an apparent IOP increase of 3.4mmHg (2).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant must meet ALL the following criteria to be considered eligible for the study:
- •Male or Female, aged 18 years or above.
- •Participant is willing and able to give informed consent for participation in the study.
- •Able and willing to comply with all study requirements.
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Any ocular surgery within 6 months
- •Known active corneal abnormalities (e.g. Keratoconus, epithelial defects)
- •Previous corrective refractive surgery (e.g. LASIK, PRK)
- •Current ocular inflammatory or infectious disease (e.g. Uveitis, keratitis, corneal ulcers)
- •Contact lens use within the last week
- •Any contraindications to use of topical anaesthetic eye drops
- •Any other pathology which the clinician or investigator believe may affect the accuracy of the CCT measurement
结局指标
主要结局
To determine whether the Occuity PM1 device is non-inferior in measuring central corneal thickness when compared to ultrasound pachymetry, the Lenstar and the Pentacam.
时间窗: upto 3 months
The central corneal thickness measurements taken by the three devices: Occuity PM1, the ultrasound pachymeter and Lenstar. Demonstrating that the Occuity PM1 Pachymeter is not inferior to the LenStar in terms of equivalency to a 95% confidence level using the Bland Altmen equation/approach.
次要结局
未报告次要终点