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OpenTrials
Completed

NCT Number: NCT03819621

Digital Imaging Assessment of Ocular Prosthesis Motility

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IRISS Medical Technologies mediGrid app

Device

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.

Primary outcomes

  1. Measurements of orbital implant and ocular prosthesis motility via the mediGrid app

    Time frame: 1 Month

    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.

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: OCUPEYE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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