Hand-held Optical Coherence Tomography Feasibility Older Hip Fracture

Not Applicable

Completed

• Conditions: Retinal Imaging
• Interventions: Diagnostic Test: Optical coherence tomography

• Registration Number: NCT04041336
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Study Start: 2019-09-03
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Optical coherence tomography	All participants will have measurements taken. There are no comparators or controls in this feasibility study

Primary Outcome Measures

Name	Time	Method
Ability to achieve good quality retinal images	30 minutes	Retinal images with signal strength \> 6 and in which retinal layers can be measured
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

Trial Locations

Locations (1)

Queen's Medical Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom