Digital Imaging Assessment of Ocular Prosthesis Motility

NCT03819621 | Completed

• 1 other identifier: SAGM1005
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Enucleated; Eye

Keywords

Prosthetic; Eye; Enucleation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

OCULAR PROSTHESIS MOTILITY

EXPERIMENTAL

All participants ocular prosthesis motility will be measured using the mediGrid app, Image J software in comparison to the ruler as a gold standard.

Device: IRISS Medical Technologies mediGrid app

Interventions

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.

OCULAR PROSTHESIS MOTILITY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

Location

Study Officials

• Mandeep Sagoo

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non-masked study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study to evaluate the mediGrid App against the gold standard rule as a measuring device.

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: January 28, 2019
• Study Start: January 30, 2019
• Primary Completion: July 18, 2019
• Study Completion: August 20, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)