Digital Imaging Assessment of Ocular Prosthesis Motility

Enucleated; Eye Clinical Trial

— OCUPEYE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819621
• Other study ID #: SAGM1005
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: August 2020
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 20, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with surgery to remove one eye

• Able to give consent and understand the study

• Able to cooperate by following instructions (keeping head still, perform gaze movements)

• Enucleation was performed with the integrated implant technique (recti muscles sutured directly to the scleral cap or the mesh around the implant in a location corresponding to muscle insertion.

Exclusion Criteria:

• Radiotherapy to socket

• Chemotherapy

• Implant exposure repair

• Secondary orbital implant

• Concurrent socket pathology:

• Socket infection

• Socket exposure

• Giant papillary conjunctivitis

• Presence of ocular motility disorders on either side of the face, such as nystagmus, known muscle restrictive disorders (thyroid eye disease, previous trauma, idiopathic orbital inflammatory disease) and neurological disorders (cranial neuropathies, multiple sclerosis).

Related Conditions & MeSH terms

• Enucleated; Eye

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust, 162 City Road	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurements of orbital implant and ocular prosthesis motility via the mediGrid app	Orbital implant motility in patient with enucleated sockets will be measured with a mediGrid app. The app will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis.	1 Month