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Retinal DystrophiesiPhotNCT01546181

Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases

An observational study of Retinal Dystrophies and Age-related Macular Degeneration, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

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

Official record
Search all trials

Trial summary

Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects. Read more about this study

Who is it for?
Ages 10 years and olderHealthy volunteers can take part
How many people
256 participants
Where
1 siteFrance
Study dates
Oct 2010to 15 Jun 2017
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 10 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: controls and patients with any kind of retinal alteration

Who may be able to join

  • over 10 years old

Who cannot join

  • ocular media opacities, unstable fixation

Trial locations and contacts

1 site in 1 country.

France1 site

  • Clinical Investigation Center 503

    Paris, 75012

Other trials in France

About this study

Official title: Observational, Follow-up Study of Adaptive Optics Retinal Imaging in Controls and During Retinal or General Diseases

Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects.

Read the detailed description

Most cases of severe visual loss in developed countries are due to retinal diseases affecting a specialized class of neurons, the photoreceptors. Currently available systems for retinal imaging in humans do not allow neuronal imaging at the cellular level, which is crucial to understand, diagnose and monitor retinal diseases. In recent years, adaptive optics (AO) fundus imaging has proven its capability to image individual photoreceptor cells in the human retina. This technology is now reaching technical maturation. A prototypic AO system (manufactured by Imagine Eyes) is currently in operation in a clinical setting (Clinical Investigation Center 503) and has proven its reliability to monitor single photoreceptors over time. Yet, the clinical evaluation of AO imaging is still in its infancy, and biomarkers issued from AO imaging have not been validated. The goal of the iPhot project is thus to optimize the process of AO imaging (from the implementation of novel technical solution to image processing and data analysis) in order to obtain morphological, quantitative and longitudinal information concerning retinal microstructures in humans. For instance, we will aim at detecting early photoreceptor damage during retinal dystrophies.

Keywords
photoreceptors, retinal pigment epithelium, adaptive optics
Medical subject headings
Retinal Dystrophies, Macular Degeneration, Hypertension, Diabetes Mellitus

What participants receive

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

Study groups in NCT01546181
Study groupRoleWhat they receive
Controlssubjects older than 10 years old, with no know ocular or general disease
Age-related macular degenerationNot described
inherited retinal dystrophiesNot described
retinal traumaNot described
toxic retinopathiesNot described
arterial hypertensive patientsNot described
diabetic patientsNot described
inflammatory diseasesNot described

What is being measured

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

  1. photoreceptor density

    the variations of the density of photoreceptors over time will be evaluated

    Measured: 01/12/2014

Timeline

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

  1. First posted7 Mar 2012 (estimated)
  2. Study startOct 2010
  3. Primary completion15 Jun 2017
  4. Study completion15 Jun 2017

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
Case-control
Time perspective
Prospective
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546181
Sponsor's protocol ID
C10-03
Other IDs
2010-A00492-37
Acronym
iPhot
Status last verified
Mar 2024
First submitted
2 Mar 2012
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Paques M, Miloudi C, Kulcsar C, Leseigneur A, Chaumette C, Koch E. High-resolution imaging of gunn's dots. Retina. 2015 Jan;35(1):120-4. doi: 10.1097/IAE.0000000000000269.

    PubMed 25077537

  • Audo I, Gocho K, Rossant F, Mohand-Said S, Loquin K, Bloch I, Sahel JA, Paques M. Functional and high-resolution retinal imaging monitoring photoreceptor damage in acute macular neuroretinopathy. Graefes Arch Clin Exp Ophthalmol. 2016 May;254(5):855-64. doi: 10.1007/s00417-015-3136-6. Epub 2015 Sep 7.

    PubMed 26344727

  • Paques M, Brolly A, Benesty J, Lerme N, Koch E, Rossant F, Bloch I, Girmens JF. Venous Nicking Without Arteriovenous Contact: The Role of the Arteriolar Microenvironment in Arteriovenous Nickings. JAMA Ophthalmol. 2015 Aug;133(8):947-50. doi: 10.1001/jamaophthalmol.2015.1132.

    PubMed 25997175

  • Miloudi C, Rossant F, Bloch I, Chaumette C, Leseigneur A, Sahel JA, Meimon S, Mrejen S, Paques M. The Negative Cone Mosaic: A New Manifestation of the Optical Stiles-Crawford Effect in Normal Eyes. Invest Ophthalmol Vis Sci. 2015 Nov;56(12):7043-50. doi: 10.1167/iovs.15-17022.

    PubMed 26523388

  • Gocho K, Sarda V, Falah S, Sahel JA, Sennlaub F, Benchaboune M, Ullern M, Paques M. Adaptive optics imaging of geographic atrophy. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3673-80. doi: 10.1167/iovs.12-10672.

    PubMed 23620431

  • Koch E, Rosenbaum D, Brolly A, Sahel JA, Chaumet-Riffaud P, Girerd X, Rossant F, Paques M. Morphometric analysis of small arteries in the human retina using adaptive optics imaging: relationship with blood pressure and focal vascular changes. J Hypertens. 2014 Apr;32(4):890-8. doi: 10.1097/HJH.0000000000000095.

    PubMed 24406779

  • Errera MH, Coisy S, Fardeau C, Sahel JA, Kallel S, Westcott M, Bodaghi B, Paques M. Retinal vasculitis imaging by adaptive optics. Ophthalmology. 2014 Jun;121(6):1311-2.e2. doi: 10.1016/j.ophtha.2013.12.036. Epub 2014 Feb 25. No abstract available.

    PubMed 24576889

  • Faure C, Gocho K, Le Mer Y, Sahel JA, Paques M, Audo I. Functional and high resolution retinal imaging assessment in a case of ocular siderosis. Doc Ophthalmol. 2014 Feb;128(1):69-75. doi: 10.1007/s10633-013-9421-y. Epub 2013 Dec 13.

    PubMed 24337723

  • Bottin C, Grieve K, Rossant F, Pedinielli A, Mrejen S, Paques M. DIRECTIONAL VARIABILITY OF FUNDUS REFLECTANCE IN ACUTE MACULAR NEURORETINOPATHY: EVIDENCE FOR A CONTRIBUTION OF THE STILES-CRAWFORD EFFECT. Retin Cases Brief Rep. 2018 Fall;12 Suppl 1:S19-S24. doi: 10.1097/ICB.0000000000000701.

    PubMed 29369084

  • Jacob J, Paques M, Krivosic V, Dupas B, Couturier A, Kulcsar C, Tadayoni R, Massin P, Gaudric A. Meaning of visualizing retinal cone mosaic on adaptive optics images. Am J Ophthalmol. 2015 Jan;159(1):118-23.e1. doi: 10.1016/j.ajo.2014.09.043. Epub 2014 Oct 2.

    PubMed 25284764

  • Rosenbaum D, Mattina A, Koch E, Rossant F, Gallo A, Kachenoura N, Paques M, Redheuil A, Girerd X. Effects of age, blood pressure and antihypertensive treatments on retinal arterioles remodeling assessed by adaptive optics. J Hypertens. 2016 Jun;34(6):1115-22. doi: 10.1097/HJH.0000000000000894.

    PubMed 27065002

  • Rosenbaum D, Kachenoura N, Koch E, Paques M, Cluzel P, Redheuil A, Girerd X. Relationships between retinal arteriole anatomy and aortic geometry and function and peripheral resistance in hypertensives. Hypertens Res. 2016 Jul;39(7):536-42. doi: 10.1038/hr.2016.26. Epub 2016 Mar 24.

    PubMed 27009576

  • Faure C, Paques M, Audo I. Electrophysiological features and multimodal imaging in ritonavir-related maculopathy. Doc Ophthalmol. 2017 Dec;135(3):241-248. doi: 10.1007/s10633-017-9612-z. Epub 2017 Sep 12.

    PubMed 28900746

  • Boileve A, Jozwiak M, Malka D, Boige V, Le Roy F, Paques M, Ducreux M. Vision loss after chemotherapy: an irinotecan-induced retinopathy. Eur J Cancer. 2019 May;112:80-82. doi: 10.1016/j.ejca.2019.02.015. Epub 2019 Apr 1. No abstract available.

    PubMed 30947025

  • Paques M, Meimon S, Rossant F, Rosenbaum D, Mrejen S, Sennlaub F, Grieve K. Adaptive optics ophthalmoscopy: Application to age-related macular degeneration and vascular diseases. Prog Retin Eye Res. 2018 Sep;66:1-16. doi: 10.1016/j.preteyeres.2018.07.001. Epub 2018 Jul 17.

    PubMed 30010022

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Dystrophies and Age-related Macular Degeneration, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

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 1 inclusion and 1 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 6 Mar 2024. 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 France. 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?

photoreceptor density (time frame: 01/12/2014). 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 NCT01546181, which also lists 20 linked publications.

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 6 Mar 2024.

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