Back to resultsHand-held Optical Coherence Tomography Feasibility Older Hip Fracture
Primary Purpose
Retinal Imaging
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optical coherence tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Retinal Imaging focused on measuring Older, Hip fracture surgery, Optical coherence tomography
Eligibility Criteria
Inclusion Criteria:
- Recent hip fracture surgery
- Age > 64 years
- No cognitive impairment
- Able to understand instructions given in English
- Consent
Exclusion Criteria:
- Presence of degenerative eye disease e.g. age-related macula degeneration, glaucoma, diabetic retinopathy, hypertensive retinopathy
- Dementia, mild cognitive impairment, Parkinson,s disease, multiple sclerosis, current delirium
Sites / Locations
- Queen's Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
All participants will have measurements taken. There are no comparators or controls in this feasibility study
Outcomes
Primary Outcome Measures
Ability to achieve good quality retinal images
Retinal images with signal strength > 6 and in which retinal layers can be measured
Ability to achieve imaging without causing pain
Patient reported pain during acquisition of images over their baseline. Scale of 0 - 10 where 0 is no increase in pain and 10 is severe increase in pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04041336
Brief Title
Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture
Official Title
Optical Coherence Tomography Feasibility in Older People Following Hip Fracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Assessment of the feasibility of achieving retinal imaging in older people with recent hips fracture surgery using hand held optical coherence tomography device
Detailed Description
Optical coherent tomography (OCT) is a device used to achieve cross-sectional imaging of tissues. It is often used in ophthalmology and also has application in dermatology, cardiology and other specialities. Usually, in adults, a table-top device is used necessitating the transfer of patients to the location of the device. In children a hand held device is used meaning the device can be taken to the patients' location. To facilitate/ help design a future study, this study's aim is to assess the feasibility of achieving retinal imaging in older people who are recovering from hip fracture surgery using a hand held device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Imaging
Keywords
Older, Hip fracture surgery, Optical coherence tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Assess the feasibility of measuring the thickness of retinal layers using a handheld optical coherence tomography device in older patients after hips fracture surgery. Consecutively recruited consenting patients will be included.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
All participants will have measurements taken. There are no comparators or controls in this feasibility study
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomography
Other Intervention Name(s)
OCT
Intervention Description
Non-invasive method of acquiring cross sectional imaging of tissues using the coherent property of light
Primary Outcome Measure Information:
Title
Ability to achieve good quality retinal images
Description
Retinal images with signal strength > 6 and in which retinal layers can be measured
Time Frame
30 minutes
Title
Ability to achieve imaging without causing pain
Description
Patient reported pain during acquisition of images over their baseline. Scale of 0 - 10 where 0 is no increase in pain and 10 is severe increase in pain
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recent hip fracture surgery
Age > 64 years
No cognitive impairment
Able to understand instructions given in English
Consent
Exclusion Criteria:
Presence of degenerative eye disease e.g. age-related macula degeneration, glaucoma, diabetic retinopathy, hypertensive retinopathy
Dementia, mild cognitive impairment, Parkinson,s disease, multiple sclerosis, current delirium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iain Moppett, PhD
Organizational Affiliation
University of Nottingham, Nottingham, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data on our primary outcome will be made available
IPD Sharing Time Frame
Start date 6 months after publication. End date 12 months after publication
IPD Sharing Access Criteria
Researchers with a valid reason as reviewed by the lead investigator
Learn more about this trial
Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture
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