Advanced OCT and Adaptive Optics Imaging in Retinal Disease (The ACAD Study)

NCT02828215 | Completed

• 1 other identifier: PATP1022
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study include using the new technology of SS-OCT (swept source optical coherence tomography) to evaluate morphological abnormalities of the vitreous, retina and choroid and to assess the repeatability of retinal and choroidal thickness measurements in retinal disease using SS-OCT. A secondary objective is to use the new imaging modality of adaptive optics to directly visualize photoreceptor mosaics and microvasculature in eyes with retinal and choroidal disease.

Conditions

Vitreous Diseases; Retinal Diseases; Choroidal Diseases

Outcome Measures

Primary Outcomes (1)

• 3 repeated measurements of choroid + retinal thickness using SD-OCT and SS-OCT and optic nerve head imaging

  3 years

Secondary Outcomes (2)

• Percentage concordance and Kappa statistics of detection of morphological abnormalities in widefield OCT and conventional filed OCT (Spectralis OCT)

  3 years

• Repeated measures of photoreceptor mosaic integrity and microsvasculature (subset of patients only) at 2 visits

  3 years

Interventions

Swept-source optical coherence tomography (SS-OCT) DEVICE

The SD-OCT provides faster images and the ability to scan more of the central retina (macula). SD-OCT simultaneously measures multiple wavelengths of reflected light across a spectrum generating up to 40,000 A-Scans (axially sample points) per second. This allows the generation of 3 dimensional faster based volumetric images of the retina. The Spectralis OCT utilises real-time hardware eye tracking to resample lines scan enhancing the signal to noise ratio by improving the image quality. The swept-source OCT (SS-OCT) uses a tuneable laser light source with a longer wavelength of light (typically 1040-1050 nm) that the light source seen in more conventional SD-OCT devices. The tissue penetration and resolution is greater with fast acquisition speeds and longer line scan lengths.

Also known as: Spectral Domain coherence topography (SD-OCT), Adaptive Optics Scanning light ophthalmoscope (AOSLO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending Moorfields Eye Hospital with a diagnosis of diseases of the vitreous, retina or choroid in at least one eye

You may qualify if:

• Patients attending Moorfields Eye Hospital with a diagnosis of diseases of the vitreous, retina or choroid in at least one eye including but not restricted to:
• Vitritis
• Vitreomacular interface abnormalities including macular hole
• Age-related macular degeneration
• Diabetic macular oedema and retinopathy
• Other causes of macular oedema
• Inherited retinal dystrophies
• Inherited macular dystrophies
• Posterior Uveitis (infectious and non-infectious)
• Retinal nerve fibre layer loss (eg due to glaucoma)
• Patients with neurodegenerative diseases such as multiple sclerosis for which there is previous literature identifying retinal/choroidal abnormalities referred by Consultant Neurologists within UCL Partners
• Male or female aged 18 years old or over.
• Ability to understand nature/purpose of study and to provide informed consent
• Ability to undergoing imaging
• Ability to follow instructions and complete study

You may not qualify if:

• History of previous significant ocular trauma
• Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

NIHR Clinical Research Facility - Moorfileds Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

• Hanumunthadu D, Keane PA, Balaskas K, Dubis AM, Kalitzeos A, Michaelides M, Patel PJ. Agreement Between Spectral-Domain and Swept-Source Optical Coherence Tomography Retinal Thickness Measurements in Macular and Retinal Disease. Ophthalmol Ther. 2021 Dec;10(4):913-922. doi: 10.1007/s40123-021-00377-8. Epub 2021 Jul 29.

  PMID: 34324166 DERIVED

MeSH Terms

Conditions

Retinal Diseases; Choroid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Uveal Diseases

Study Officials

• Praveen Patel, MBBChir MA FRCOphth MD(Res)

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: June 6, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)