Clinical trial NCT03819621: Digital Imaging Assessment of Ocular Prosthesis Motility
Official title: Objective Assessment of Orbital Implant and Ocular Prosthesis Motility Using a Digital Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enucleated; Eye
Keywords: Prosthetic
Eye
Enucleation
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study to evaluate the mediGrid App against the gold standard rule as a measuring device.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measurements of orbital implant and ocular prosthesis motility via the mediGrid app
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Mandeep Sagoo
role: PRINCIPAL_INVESTIGATOR
References: