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Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture

Sponsor
University of Nottingham (Other)
Overall Status
Completed
CT.gov ID
NCT04041336
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
12.9
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Optical coherence tomography
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
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.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
Actual Study Start Date :
Sep 3, 2019
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

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 Names:
  • OCT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ability to achieve good quality retinal images [30 minutes]

      Retinal images with signal strength > 6 and in which retinal layers can be measured

    2. Ability to achieve imaging without causing pain [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen's Medical Centre Nottingham Nottinghamshire United Kingdom NG7 2UH

    Sponsors and Collaborators

    • University of Nottingham

    Investigators

    • Principal Investigator: Iain Moppett, PhD, University of Nottingham, Nottingham, UK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Nottingham
    ClinicalTrials.gov Identifier:
    NCT04041336
    Other Study ID Numbers:
    • 19006
    First Posted:
    Aug 1, 2019
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Hip Fractures

    Study Results

    No Results Posted as of May 11, 2022