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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).
Full description
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.
Evaluation of clinical data that are relevant to the proposed clinical investigation.
The data will be statistically analysed to determine if a Click2Print ocular prosthesis is non inferior in motility and in comparison, to an analogue ocular prosthesis. Cosmesis will be assessed by standard comparison of subjective outcomes.
Data subjects will be requested to complete a general ocular prosthesis questionnaire. The questionnaire will help to evaluate how a Click2Print ocular prosthesis compares to the current analogue ocular prosthesis. Topics covered in the questionnaire will be:
Risk to benefit rationale.
The result of the risk management process is that the residual risks, as identified in the risk analysis, as well as risk(s) to the subject associated with the clinical procedure are outweighed by the anticipated benefits to the subjects.
Procedures to be taken in case of adverse events:
All adverse events and serious adverse events will be recorded in the medical records and case report form. All serious adverse events will be reported to the sponsor.
Description of the measures taken to minimize or avoid bias, including randomization and blinding/masking.
Data subjects enrolled in the clinical investigation will be allocated a study number. Randomisation allocation of first ocular prosthesis wear by patient will be assigned, using allocation concealment, against consecutive Study IDs. After 4 months, patient will crossover to receive the alternative prosthesis. The randomisation list will be generated centrally using random permutated blocks of varying sizes in STATA statistical software. Seed number will be recorded for future reference in the original randomisation list.
Demographics will be such that the data subject cannot be identified. Every effort will be made to mask the patient and investigators from knowing which type of prosthesis is being worn during the trial.
The trial statistician who is analysing trial data will be masked until primary analysis is completed.
Methods and timing for assessing, recording, and analysing variables.
Monitoring plan
Case Report Forms will be completed by the investigator and/or delegates within 2 working days of the study visit. All data from the examinations and investigations will be transferred to media provided by the sponsor and collected at the time of collection.
Moorfields Eye Hospital NHS Foundation Trust, the sponsor, will perform interim monitoring visits. These will be undertaken by an independent monitor contracted with Moorfields.
Trial Management Group(TMG)
The TMG will monitor all aspects of the conduct and progress of the trial, ensure that protocol is adhered to and take appropriate action to safeguard participants and the quality of the trial itself. The group will meet to discuss any issues with data quality and any concerns will be discussed at the trial steering committee
Independent Data Monitoring Committee (IDMC)
An IDMC will monitor the trial progress and patient safety data, at intervals, while the clinical trial is ongoing. The IDMC will make recommendations to the TSC regarding continuation, stopping or any modification to the trial.
Trial Steering Committee (TSC)
A TSC will be set up to provide the overall supervision of the trial and ensure that it is being conducted in accordance with the principles of good clinical practice and the relevant regulations. The TSC will have an independent chair and include members (including one lay member) who are independent of the investigators, their employing organisations, funders and sponsors. The TSC will agree the trial protocol and any protocol amendments, monitor trial progress, monitor trial conduct and advise on scientific credibility. The TSC will consider and act, as appropriate, upon the recommendations of the IDMC or equivalent and ultimately carries the responsibility for deciding whether a trial needs to be stopped on grounds of safety or efficacy.
Confidentiality All data will be handled in accordance with the General Data Protection Regulation (GDPR) and United Kingdom Data Protection Act 2018. The case report forms will not bear the subject's name or other personal identifiable data. The trial identification number will be used for identification. Subjects will be assigned a trial identification number by the study site sequentially starting with {01} upon enrolment into the study. The study site will maintain a master Subject Identification Log.
Record keeping and archiving Archiving will be authorised by the Sponsor following submission of the end of study report. Chief Investigators are responsible for the secure archiving of essential trial documents as per trust policy. All essential documents will be archived in line with the sponsor archiving procedure after completion of trial. Destruction of essential documents will require authorisation from the Sponsor.
Statistical Analysis Plan:
The statistical analysis will be completed by Dr. Andrew W. Stacey. The analysis will be completed using the R Statistical Environment software. The following analyses will be completed:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
99 participants in 2 patient groups
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Central trial contact
Stephen Bell
Data sourced from clinicaltrials.gov
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