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

NCT03326908 | Completed

• 1 other identifier: MMT_2017_16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tomography, Optical Coherence; Retina

Outcome Measures

Primary Outcomes (1)

• Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment

  1 hour after baseline

Study Arms (2)

Normal conditions of light exposure

OTHER

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

Device: Spectral Domain Optical Coherence Tomography

Light variations

OTHER

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

Device: Spectral Domain Optical Coherence Tomography

Interventions

Spectral Domain Optical Coherence Tomography DEVICE

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

Light variations; Normal conditions of light exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or older
• Consent to participate

You may not qualify if:

• Retinal abnormalities

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 33393736 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: October 12, 2017
• Primary Completion: January 10, 2018
• Study Completion: January 24, 2018
• Last Updated: January 6, 2026

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)