A Prospective Observational Study to Investigate the Role of the Biomechanics of the Cornea in Identifying Glaucoma or Anterior Eye Diseases and Create an IT Tool Able to Distinguish Between Them
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- First applanation time
研究概览
简要总结
The aim of the study is to use machine learning to develop an IT tool able to differentiate between eye conditions analysing corneal biomechanical data.
详细描述
Data will be collected using two different commercially available devices that are able to measure corneal biomechanics. Corneal biomechanics will be measured in participants with different conditions: glaucoma, ocular hypertension, corneal conditions, and healthy controls as it is well established that the above-mentioned conditions cause changes in corneal biomechanical properties.
Corneal biomechanics are the mechanical properties of the cornea, as rigidity, elasticity and it is possible to measure them using two devices: Ocular Response Analyzer (ORA) or Corneal Visualization Scheimpflug Technology (Corvis ST). Both devices use a puff of air to temporally flatten the cornea and derive the properties of the tissue.
Participants with ocular conditions will be recruited at Birmingham and Midlands Eye Centre (BMEC) at the Glaucoma and Anterior Eye clinics among patients attending for their routine clinical appointment. Healthy controls will be recruited at Aston University. This study requires only one visit and there is no need of follow up.
A portion of the data collected will be used to train machine learning algorithms to differentiate between conditions, the remaining data will be used to test the accuracy of newly created algorithms. The algorithm will be developed using Orange Data Mining.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age above 18 years old.
- •Participants who are able to give informed consent.
- •Study groups: Patients with diagnosis of glaucoma or corneal disease or ocular hypertension. Patients that are having a treatment (medications or surgery) for glaucoma or ocular hypertension or corneal conditions.
- •Control group: people with no diagnosis or treatment of previous pathologies.
排除标准
- •Age below
- •Participants who are not able to give informed consent.
- •Patients with eye conditions not within the inclusion criteria.
- •Patients with respiratory distress or significant head tremor.
- •Patients who are in pain or unable to remain seated for duration of measurements.
- •Participants that during the visit are wearing contact lenses. The wear of contact lenses can alter the measure of corneal biomechanics.
结局指标
主要结局
First applanation time
时间窗: Day 1
Time frame of the first applanation of the cornea, measured using Corivs ST \[s\]
Second applanation lenght
时间窗: Day 1
Lenght of the second applanation of the cornea, measured using Corivs ST \[mm\]
First applanation velocity
时间窗: Day 1
Velocity during the first applanation of the cornea, measured using Corivs ST \[m/s\]
First applanation lenght
时间窗: Day 1
Lenght of the first applanation of the cornea, measured using Corivs ST \[mm\]
Highest concavity peak distance
时间窗: Day 1
Distance between the 2 surrounding peaks at the highest concavity, measured using Corivs ST \[mm\]
Highest concavity radius
时间窗: Day 1
Radius of curvature at highest concavity, measured using Corivs ST \[mm\]
Second applanation velocity
时间窗: Day 1
Velocity during the second applanation of the cornea, measured using Corivs ST \[m/s\]
Highest concavity deformation amplitude
时间窗: Day 1
Maximal displacement of corneal apex between normal corneal shape and highest concavity, measured using Corivs ST \[mm\]
Second applanation time
时间窗: Day 1
Time frame of the second applanation of the cornea, measured using Corivs ST \[s\]
Highest concavity time
时间窗: Day 1
Time frame at highest concavity, measured using Corivs ST \[s\]
Corneal resistance factor
时间窗: Day 1
Overall resistance of the cornea, measured using ORA \[mmHg\]
Corneal hysteresis
时间窗: Day 1
Difference in terms of intensity of puff of air between the first and second applanation, measured using ORA \[mmHg\]
次要结局
- Pachymetry(Day 1)
- Intraocular pressure measured using ORA(Day 1)
- Intraocular pressure measured using Corvis ST(Day 1)