Description of the Interdigitation Retinal Area by SD-OCT: An Exploratory Study

NCT ID: NCT03326908

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2018-01-24

Brief Summary

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Improvement of retinal medical imaging opens new perspectives for exploring the retinal structures. Optical coherence spectral domain (SD-OCT), which has been widely used in the last ten years, is certainly the most advanced device. In the analysis of patients without retinal disease using SD-OCT, granulations in the interdigitation area were observed. These granulations have never been described with this device. They could correspond either to the degradation products of the external segments of the photoreceptors or to melanosomes. A descriptive study of these granulations at different examination times and in different lighting situations would allow us to obtain essential information for a better understanding of this area. Based on the results, larger studies could explore this area more finely in retinal pathologies involving dysfunctions of photoreceptors or of the pigmentary epithelium.

Detailed Description

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Conditions

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Tomography, Optical Coherence Retina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal conditions of light exposure

Spectral Domain Optical Coherence Tomography (SD-OCT):

Five SD-OCTs will be produced under the same lighting conditions (photopic).

* At baseline
* 20 minutes after baseline
* 25 minutes after baseline
* 45 minutes after baseline
* 60 minutes after baseline

Group Type OTHER

Spectral Domain Optical Coherence Tomography

Intervention Type DEVICE

Five SD-OCTs will be performed with various conditions of enlightenment.

Light variations

Spectral Domain Optical Coherence Tomography (SD-OCT):

Five SD-OCT will be performed:

* at baseline, in a room with photopic artificial lighting (400 lux)
* after a period of adaptation to the dark (20 minutes in the dark: 0 lux)
* after 5 min of retinal glare, obtained by means of a projection of light of 1000 lux on the fundus of eye
* 15 minutes after this period of retinal glare, in photopic artificial lighting
* 30 minutes after the period of retinal glare, in photopic artificial lighting

Group Type OTHER

Spectral Domain Optical Coherence Tomography

Intervention Type DEVICE

Five SD-OCTs will be performed with various conditions of enlightenment.

Interventions

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Spectral Domain Optical Coherence Tomography

Five SD-OCTs will be performed with various conditions of enlightenment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient aged 18 years or older
* Consent to participate

Exclusion Criteria

* Retinal abnormalities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique A. de Rothschild

Paris, , France

Site Status

Countries

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France

References

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Mathis T, Vasseur V, Zuber K, Arej N, Loria O, Kodjikian L, Sennlaub F, Mauget-Faysse M. Light-induced modifications of the outer retinal hyperreflective layers on spectral-domain optical coherence tomography in humans: an experimental study. Acta Ophthalmol. 2021 Nov;99(7):765-772. doi: 10.1111/aos.14723. Epub 2021 Jan 4.

Reference Type RESULT
PMID: 33393736 (View on PubMed)

Other Identifiers

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MMT_2017_16

Identifier Type: -

Identifier Source: org_study_id

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