An Open-label, Non-Interventional, Non-Randomized, Observational, Single Arm Study to evaluate Accuracy and Safety of Over the Eyelid Tonometry OET Accuway , in measuring Intraocular Pressure compared to Goldmann Applanation Tonometry (GAT) and Air-Puff Tonometry (APT).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Accuracy of IOP measurements as determined by the mean difference between the novel
研究概览
简要总结
The prospective, multicenter, open-label, single-arm study will adopt a design aiming to evaluate various intraocular pressure (IOP) measurement techniques among patients with different ocular conditions, including glaucoma suspects, or those with normal intraocular pressure. A total of 102 selected subjects, encompassing 204 eyes, will be enrolled in this comparative study, with recruitment occurring over a 2-month period, comprising those with normal (IOP 11-22 mm of Hg) and abnormal IOP (Low IOP less than 10mm of Hg and High IOP greater than 22mm of Hg). Air puff tonometry (APT) will be administered first, followed by over-the-eyelid tonometry OET Accuway, and finally Goldmann applanation tonometry (GAT) in both eyes to prevent applanation-induced lowering of IOP. For OET Accuway a mean of three readings will be recorded. A 10-minute break will be set between each IOP measurement to minimize after-measurement fluctuations in the IOP. Prior to any study-related procedures, informed consent will be diligently obtained from each participant, adhering strictly to ethical guidelines. Baseline assessments, inclusive of comprehensive medical history, ocular examination, and initial IOP measurements employing all three tonometry techniques (OET [Accuway], APT, GAT), will be meticulously performed on the same day. Data collection will employ a standardized form, capturing demographic details such as age, gender, and IOP measurements obtained from all three tonometers. The study arm will be single, focusing on OET (Accuway)/GAT/APT within subjects. The observational/diagnostic IPs will include Over-the-eyelid tonometry OET (Accuway) as the observational diagnostic device and Goldmann tonometry (GAT) and Air puff tonometry (APT) as gold standard diagnostic devices. The expected study timeline is set at 3 months, with a 2-month enrolment period.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal IOP:
- •Male or Female: Age ≥ 18 years Male or Female
- •Healthy volunteers with no history of corneal disease, ocular hypertension, or glaucoma age and gender match control, non Glaucoma cases.
- •Willing and able to provide informed consent for participation in the study.
- •Ability to undergo intraocular pressure (IOP) measurements using Air puff tonometry, over-the eyelid tonometry, and Goldmann tonometry Abnormal IOP:
- •Male or Female: Age ≥ 18 years 2.
排除标准
- •Participants under the age of
- •Inability to provide informed consent
- •Known contraindications to any of the tonometry techniques (Air puff tonometry, over-the-eyelid tonometry, Goldmann tonometry), have significant corneal abnormalities, acute eye infections or have a history of ocular surgery within the past 6 months.
- •Chronic conjunctivitis, cornea pathology, including keratitis, keratotomy, cornea dimness, after penetrating keratoplasty, keratoprosthesis, high degree of ametropia, astigmatism, Edema, Injury to the eyelid, upper lid pathology (inflammatory diseases, scars, eyelid deformation).
- •Expressed sclera and/or conjunctiva pathology in the measuring area, Viral infections, allergic reactions, dry eye syndrome, Post corneal surgery, laser refractive correction of the eyesight.
- •Significant corneal abnormalities and acute eye infections.
结局指标
主要结局
Accuracy of IOP measurements as determined by the mean difference between the novel
时间窗: At Baseline Visit
over-the-eyelid tonometry device and the GAT and APT devices
时间窗: At Baseline Visit
次要结局
- Intra-device & inter-device variability in IOP measurements.(Patient comfort & preference for the different tonometry methods.)
研究者
Dr Arjun Ahuja
Sadhu-Kamal Eye Hospital