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

Not Applicable

Completed

• Conditions: Retina; Tomography, Optical Coherence
• Interventions: Device: Spectral Domain Optical Coherence Tomography

• Registration Number: NCT03326908
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-12
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Status Verified: 2018-01
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-24
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient aged 18 years or older
• Consent to participate

Exclusion Criteria

• Retinal abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light variations	Spectral Domain Optical Coherence Tomography	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
Normal conditions of light exposure	Spectral Domain Optical Coherence Tomography	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

Primary Outcome Measures

Name	Time	Method
Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment	1 hour after baseline

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France