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Clinical Trials/NCT03843840
NCT03843840CompletedNot Applicable

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

Moorfields Eye Hospital NHS Foundation Trust1 site in 1 country60 target enrollmentStarted: February 15, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Test retest reliability

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Test retest reliability

Time Frame: 14 months

Comparison of device test retest variability with those of standard OCT for measurement of tissue reflectivity.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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