Status:
COMPLETED
Digital Imaging Assessment of Ocular Prosthesis Motility
Lead Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Conditions:
Enucleated; Eye
Eligibility:
All Genders
18+ years
Phase:
NA
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 sm...
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 discomfo...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03819621
Start Date
January 30 2019
End Date
August 20 2019
Last Update
August 20 2020
Active Locations (1)
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1
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, United Kingdom, EC1V 2PD