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Vitreous DiseasesACADNCT02828215

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

An observational study of Vitreous Diseases and Retinal Diseases, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Swept-source optical coherence tomography (SS-OCT)
Type of treatment
Medical device
How many people
300 participants
Where
1 siteUnited Kingdom
Study dates
1 Jul 2015to 6 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • NIHR Clinical Research Facility - Moorfileds Eye Hospital

    London, EC1V 2PD

Other trials in United Kingdom

About this study

Official title: A Prospective Study to Evaluate Swept-Source OCT and Adaptive Optics Imaging of Diseases of the Vitreous, Retina and Choroid

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.

Read the detailed description

Diseases affecting the vitreous, retina and choroid are among the commonest causes of sight-loss and vision impairment in England and Wales.

These diseases may display a wide range of pathological features including vitreous, retinal and subretinal haemorrhage; macular fluid; choroidal inflammation and choroidal masses.

The retina is a 'window to the brain' and there is increasing evidence that neurodegenerative disorders such as Multiple Sclerosis, Parkinsons Disease and Alzheimers Disease have retinal manifestations which may have prognostic implications, afford earlier diagnosis, and potentially act as surrogate endpoints for treatment trials.

In 2012, a further advance in OCT technology was brought to market with the arrival of the first commercial available swept-source OCT (SS-OCT) device (the Topcon DRI OCT). SS-OCT technology uses a tuneable laser light source with a longer wavelength of light (typically 1040-1050 nm central wavelength) than the light sources seen in more conventional SD-OCT devices. This leads to greater tissue penetration with less backscatter from the RPE, producing images of the choroid with greater resolution with fast image acquisition speeds (100,000 A scans/s) and longer line scan lengths. The ability to take rapid scans with the only commercially available SS-OCT device (the DRI, Tocon Inc. Paramus, NY, USA) also enhances image quality by line scan averaging capability.

The high axial resolution of OCT allows discrimination of the distinct retinal layers that are affected differentially in different diseases. More direct visualisation of the photoreceptor layer is afforded by use of an Adaptive Optics Scanning Light Ophthalmoscope (AOSLO), which provides excellent lateral resolution and allows direct visualisation of the cone and rod photoreceptor mosaics in vivo by correcting for ocular aberrations and resulting in a lateral comparable with histopathological sections.

In this study AO images will be correlated with SD- and SS-OCT and used to comprehensively assess the integrity of the photoreceptor mosaic. Furthermore AO and OCT will be used to measure nerve fibre layer loss and optic disc changes if relevant to the disease.

The imaging modalities used in this study will be spectral domain optical coherence topography (SD-OCT), swept source optical coherence tomography (SS-OCT), and adaptive optics scanning light ophthalmoscope (AOSLO)

The study will examine 300 patients (up to 600 eyes) in a single visit with a further Adaptive Optics (AO) imaging taken in a subset of patients (up to 200).

Patients in whom AO imaging was possible from a technical perspective will be invited back for further imaging after 6-12 months (at a standard NHS follow up visit) to probe longitudinal changes.

An examiner will scan the participants study eye(s) on the same day on each of the 3 imaging modalities SD-OCT, SS-OCT and AOSLO.

Finally a questionnaire will be used to explore whether participants preferred one OCT imaging modality over the other (SS-OCT vs SD-OCT).

Being tested
Swept-source optical coherence tomography (SS-OCT)
Medical subject headings
Retinal Diseases, Choroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Swept-source optical coherence tomography (SS-OCT)Device

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

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3 repeated measurements of choroid + retinal thickness using SD-OCT and SS-OCT and optic nerve head imaging

    Measured: 3 years

Secondary outcomes (2)
  1. Percentage concordance and Kappa statistics of detection of morphological abnormalities in widefield OCT and conventional filed OCT (Spectralis OCT)

    Measured: 3 years

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion1 Dec 2019
  4. Study completion6 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02828215
Sponsor's protocol ID
PATP1022
Acronym
ACAD
Status last verified
Sep 2020
First submitted
6 Jul 2016
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34324166

Questions about this trial

What is this clinical trial studying?

An observational study of Vitreous Diseases and Retinal Diseases, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3 repeated measurements of choroid + retinal thickness using SD-OCT and SS-OCT and optic nerve head imaging (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02828215, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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