Digital imaging assessment of ocular prosthesis motility v1.0
Research type
Research Study
Full title
Objective assessment of orbital implant and ocular prosthesis motility using a digital imaging.
IRAS ID
245887
Contact name
Mandeep S Sagoo
Contact email
Sponsor organisation
Deputy Director of R&D Moorfields Biomedical Research Centre
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
The fit and function of an ocular prosthetic determines the effective motility (movement) within the patient’s eye socket. A poor fitting ocular prosthesis will lead to poor motility, patient discomfort and increased mucus discharge, and can risk the integrity of the anterior surface of the implanted orbit. Currently the method to determine best fit of the ocular prosthesis is dependent upon the ocularist’s skill in adding or subtracting material from the wax model that is replicated from an initial alginate impression of the patient’s eye socket.
The proposal of this study is to utilise digital imaging to capture images to measure the motility of both the orbital implant and the ocular prosthesis. Two methods will be compared against gold standard: excursion measurements on a photograph using digital software (Image J) versus use of a smart phone app (an iOS app known as mediGrid (IRISS Medical Technologies, UK; CE Marked, HIPAA compliant). The gold standard is excursion measure by ruler placed next to the prosthesis. This study will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis and analysis will include comparisons between hydroxyapatite and acrylic implants and in patients with post-enucleation socket syndrome (PESS). A part of this study will also evaluate the accuracy of the two softwares Image J as well as the mediGrid smartphone app in measuring prosthesis motility by comparing it to the ruler as a “gold” standard.
The results from this study will establish the validity of a digital method to objectively measure orbital implant and ocular prosthesis motility. It will also establish normative data for ocular prosthesis motility, investigate differences between type of orbital implant and in PESS. This data will become a platform for investigating further advances in ocular prosthetics, such as 3D printed basic ocular prosthetics.REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1990
Date of REC Opinion
12 Dec 2018
REC opinion
Further Information Favourable Opinion