Pseudonymised Single Site Investigation Into Unique Patient Data Acquisition Using Anterior Segment Optical Coherence Tomography for the Digital Design and Manufacture of Ocular Prosthesis and Randomised Crossover Trial of Analogue Versus Digital Ocular Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Comparison of prosthesis motility utilising an excursion assessment to prove non-inferiority of the digital ocular prosthesis
研究概览
简要总结
To undertake a randomised crossover trial in human subjects the Click2Print ocular prosthesis versus an analogue ocular prosthesis demonstrating non-inferiority in the assessment of ocular prosthesis motility, cosmesis, fit and function, comfort, mucous discharge and benefits of use in daily life in 40 data subjects (Crossover Trial).
详细描述
For this project, the investigators will conduct a randomised controlled crossover trial comparing the efficacy, safety and performance of the Click2Print ocular prosthesis versus the handmade analogue ocular prosthesis.
A non-invasive image is taken on an anterior segment optical coherence tomography device (AS-OCT), which captures data subject data of the anophthalmic socket so that the anatomy of the anterior orbit can be outlined. At the same sitting the data of the fellow eye is captured by taking an AS-OCT of the volume of the cornea and iris.
Simultaneously a colour calibrated image of the fellow eye is captured. This unique data will serve as a template for the design of the bespoke Click2Print ocular prosthesis. The investigators anticipate that the Click2Print ocular prosthesis will not be inferior in fit and function to the handmade analogue ocular prosthesis. The Click2Print ocular prosthesis is also expected to match the analogue ocular prosthesis in the objective measures of prosthesis motility and cosmesis and that there will be no adverse events in terms of the socket and general health.
Statistical methodology and analysis:
The study design is a randomised, crossover trial of Click2Print ocular prosthesis versus analogue ocular prosthesis. The methods will include a non-inferiority comparison of ocular motility between the two prosthesis types, and a standard comparison of subjective outcomes including: cosmesis, comfort, and durability of colour and structure. The analysis will include the development of a non-inferiority margin for the comparison of motility, non-parametric significance tests for questionnaire data, and parametric significance tests for volume data. The alpha level is 0.05 and superiority significance tests will be two-tailed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Demographics will be such that the data subject cannot be identified. It will not be possible to mask the ocularist, data manager or the trial manager. Every effort will be made to mask the patient and investigators from knowing which type of prosthesis is being worn during the trial. However, due to the differing methods of manufacture of a digital artificial eye compared to the traditional artificial eye, upon close inspection, it may be possible to denote differences in the cosmetic appearance. Should the participant ask or comment on which type of artificial eye they are wearing to the ocularist or research member then a scripted response will be provided.
The trial statistician who is analysing trial data will be masked until primary analysis is completed. Un-masking of the ocular prosthesis will occur after confirmation of primary analysis has been performed.
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
- •Adults aged 18 years and over
- •Adults with surgery to remove one eye with at least 1-year follow-up
- •Able to give consent and understand the study
- •Able to cooperate by following instructions
排除标准
- •- Adults with surgery to remove one eye with less than 1-year follow-up.
- •Concurrent socket pathology (Socket infection or exposure).
- •Giant papillary conjunctivitis.
- •Presence of ocular motility disorders on either side of the face, muscle restrictive disorders, previous trauma, idiopathic orbital inflammatory disease and neurological disorders (cranial neuropathies, multiple sclerosis).
- •Data subjects unable to understand the study and unable to give informed consent.
- •Data subjects considered vulnerable.
- •Ongoing participation in another clinical study.
结局指标
主要结局
Comparison of prosthesis motility utilising an excursion assessment to prove non-inferiority of the digital ocular prosthesis
时间窗: 8 months
Each subject will use two different ocular prostheses for an extended period of time and the motility of each will be compared. Each ocular prosthesis will be worn for 4 months. Motility will be assessed at the beginning and after 3 month period of wear for each prosthesis. Motility will be measured by assessing the ocular prosthesis excursion in four angles of gaze. The distance from straight ahead gaze compared to left, right, up and down gaze will be measured in millimetres and recorded on the case report form. These measurements will then be used to compute a total motility score. The data subject will cross-over to wearing the comparator type prosthesis and the motility assessment will be repeated at the beginning and after three month period. The total motility scores of type 1 and type 2 prostheses will then be compared to determine if the digital ocular prosthesis motility is non-inferior to the gold-standard handmade prosthesis.
次要结局
未报告次要终点