Click2Print Artificial Eyes

NCT05093348 | Completed DMC

• 1 other identifier: SAGM1006
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Enucleated; Eye; Evisceration; Traumatic, Eye

Keywords

Enucleated; Artificial eye; Prosthesis; Eviscerated

Outcome Measures

Primary Outcomes (1)

• Comparison of prosthesis motility utilising an excursion assessment to prove non-inferiority of the digital ocular prosthesis

  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.

  8 months

Study Arms (2)

Click2Print digital Artificial Eye

ACTIVE COMPARATOR

Supply and fit a digitally designed and manufactured ocular prosthesis for four months in comparison to the current hand-made ocular prosthesis in a cross over trial

Device: Click2Print artificial eye

Current hand made artificial eye

ACTIVE COMPARATOR

Wear the hand-made artificial eye for four months and compare to the digitally design ed and manufactured artificial eye

Device: Hand-made artificial eye

Interventions

Click2Print artificial eye DEVICE

Digitally designed and manufactured ocular prosthesis

Click2Print digital Artificial Eye

Hand-made artificial eye DEVICE

Hand-made artificial eye

Current hand made artificial eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

Location

Study Officials

• Mandeep Sagoo

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pseudonymised single site investigation randomised crossover trial

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: October 26, 2021
• Study Start: November 25, 2021
• Primary Completion: July 16, 2023
• Study Completion: July 16, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)