NCT03819621

Digital Imaging Assessment of Ocular Prosthesis Motility

Objective Assessment of Orbital Implant and Ocular Prosthesis Motility Using a Digital Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis. This will be measured using two software applications - Image J as well as the mediGrid smartphone app in measuring prosthesis motility by comparing it to the ruler as a "gold" standard.

Detailed description

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: 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). 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 without an orbital implant, also known as 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.

Conditions

• Enucleated; Eye

Interventions

Type	Name	Description
DEVICE	IRISS Medical Technologies mediGrid app	IRISS mediGrid is standalone software, loaded on a mobile electronic platform, which is intended to record and document ophthalmic and other bodily characteristics and to aid in the diagnosis of abnormalities.

Timeline

• Start date: 2019-01-30
• Primary completion: 2019-07-18
• Completion: 2019-08-20
• First posted: 2019-01-28
• Last updated: 2020-08-20

Locations

1 site across 1 country: United Kingdom