Digital Imaging Assessment of Ocular Prosthesis Motility (OCUPEYE)

Moorfields Eye Hospital NHS Foundation Trust

Status

Completed

Conditions

Enucleated; Eye

Treatments

Device: IRISS Medical Technologies mediGrid app

Study type

Interventional

Funder types

Other

Identifiers

NCT03819621

SAGM1005

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).