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OCT Feasibility Older Hip Fracture

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ClinicalTrials.gov Identifier: NCT04041336
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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

Condition or disease Intervention/treatment Phase
Retinal Imaging Diagnostic Test: Optical coherence tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography Feasibility in Older People Following Hip Fracture Surgery
Estimated Study Start Date : August 8, 2019
Estimated Primary Completion Date : November 7, 2019
Estimated Study Completion Date : December 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All participants
All participants will have measurements taken. There are no comparators or controls in this feasibility study
Diagnostic Test: Optical coherence tomography
Non-invasive method of acquiring cross sectional imaging of tissues using the coherent property of light
Other Name: OCT




Primary Outcome Measures :
  1. Ability to achieve good quality retinal images [ Time Frame: 30 minutes ]
    Retinal images with signal strength > 6 and in which retinal layers can be measured

  2. Ability to achieve imaging without causing pain [ Time Frame: Immediate ]
    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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041336


Contacts
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Contact: Iain Moppett, PhD 01158230959 iain.moppett@nottingham.ac.uk
Contact: Abi Noah, FRCA 01158231011 abi.noah@nottingham.ac.uk

Locations
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United Kingdom
Queen's Medical Centre Not yet recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: Iain Moppett, PhD    01158230959    iain.moppett@nottingham.ac.uk   
Contact: Abi Noah, FRCA    01152831011    abi.noah@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Iain Moppett, PhD University of Nottingham, Nottingham, UK

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04041336     History of Changes
Other Study ID Numbers: 19006
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data on our primary outcome will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Start date 6 months after publication. End date 12 months after publication
Access Criteria: Researchers with a valid reason as reviewed by the lead investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Older
Hip fracture surgery
Optical coherence tomography
Additional relevant MeSH terms:
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Hip Fractures
Fractures, Bone
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries