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

January 2, 2026 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Description of the Interdigitation Retinal Area by SD-OCT (Spectral Domain Optical Coherence Tomography): An Exploratory Study (ODIGIT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Fondation Ophtalmologique A. De Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient aged 18 years or older
  • Consent to participate

Exclusion Criteria:

  • Retinal abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: Spectral Domain Optical Coherence Tomography
Five SD-OCTs will be performed with various conditions of enlightenment.
Other: 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
Device: Spectral Domain Optical Coherence Tomography
Five SD-OCTs will be performed with various conditions of enlightenment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of the number of hyperreflective granulations in the interdigitation area according to time and enlightenment
Time Frame: 1 hour after baseline
1 hour after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2017

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

January 24, 2018

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MMT_2017_16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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