Dual Wavelength OCT

Diabetic Retinopathy Clinical Trial

Official title:

Combined Coaxial Optical Coherence Tomography System to Image the Retina and Choroidal Structures and Estimate Tissue Reflectivity in Healthy and Diseased Retinas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843840
• Other study ID #: TUFA1040
• Status: Completed
• Start date: February 15, 2019
• Est. completion date: October 21, 2020

Study information

• Verified date: April 2022
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.

Description:

Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 21, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18
• Ability to consent
• Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
• clinical care

Exclusion Criteria:

• Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
• the retina and/or choroidal substructures in the opinion of the investigator
• Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.

Related Conditions & MeSH terms

• AMD
• Diabetic Retinopathy
• Retinal Degeneration
• Retinal Dystrophies

Intervention

Device:
• Combined Coaxial Optical Coherence Tomography
Taking images of the retina with two wavelengths

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust, 162 City Road	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test retest reliability	Comparison of device test retest variability with those of standard OCT for measurement of tissue reflectivity.	14 months