Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture

Retinal Imaging Clinical Trial

Official title:

Optical Coherence Tomography Feasibility in Older People Following Hip Fracture Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041336
• Other study ID #: 19006
• Status: Completed
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: May 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of the feasibility of achieving retinal imaging in older people with recent hips fracture surgery using hand held optical coherence tomography device

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Fractures
• Retinal Imaging

Intervention

Diagnostic Test:
• Optical coherence tomography
Non-invasive method of acquiring cross sectional imaging of tissues using the coherent property of light

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to achieve good quality retinal images	Retinal images with signal strength > 6 and in which retinal layers can be measured	30 minutes
Primary	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