Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture

NCT04041336 | Completed

• 1 other identifier: 19006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Retinal Imaging

Keywords

Older; Hip fracture surgery; Optical coherence tomography

Outcome Measures

Primary Outcomes (2)

• Ability to achieve good quality retinal images

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

  30 minutes

• 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

  Immediate

Study Arms (1)

All participants

EXPERIMENTAL

All participants will have measurements taken. There are no comparators or controls in this feasibility study

Diagnostic Test: Optical coherence tomography

Interventions

Optical coherence tomography DIAGNOSTIC_TEST

Non-invasive method of acquiring cross sectional imaging of tissues using the coherent property of light

Also known as: OCT

All participants

Eligibility Criteria

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

You may qualify if:

• Recent hip fracture surgery
• Age \> 64 years
• No cognitive impairment
• Able to understand instructions given in English
• Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queen's Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Iain Moppett, PhD

  University of Nottingham, Nottingham, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 1, 2019
• Study Start: September 3, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

GB (1)