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Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients (OCTADIAL)

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ClinicalTrials.gov Identifier: NCT03804216
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief Summary:

Little knowledge exist on the short and long-term ophthalmological effect of the dialysis. Some studies stated a variation of the thickness subfoveal choroidal before and after a session of dialyse as well as variations of the coat of optical fibers measured in OCT.

The Optical Coherence Tomography angiography OCT is a not invasive imaging technique which is now a part of examinations of investigation in imaging of retina. This technique allows to study the retinal macula vascularization without injection of contrast agent and thus allows to deepen the knowledge in medical domains where the exploration was to limited because of the invasive character of the examinations.

The hypothesis of this project is that hemodynamic change during the hemodialysis may lead fine variations of the retinal vascularization in the short-term (the day of the dialysis) but also in the longer term (over 1 year).


Condition or disease Intervention/treatment
Renal Failure Other: Multimodal Imaging Analysis

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Multimodal Imaging Analysis
    The patients are seen in consultation ophthalmological before and the 1 hour after their session of dialysis. THE OCT angiography and other not invasive ophthalmological examinations will be realized during the follow-up
    Other Name: SD-OCT and OCT Angiography


Primary Outcome Measures :
  1. vascular density before hemodialysis [ Time Frame: before hemodialysis ]
    Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

  2. vascular density 1 hour after hemodialysis [ Time Frame: 1 hour after hemodialysis ]
    Analysis of the variation of the vascular densities in retinal macula in the central 6 mm


Secondary Outcome Measures :
  1. vascular density 1 month after dialysis [ Time Frame: 1 month after dialysis ]
    Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

  2. vascular density 3 month after dialysis [ Time Frame: 3 month after dialysis ]
    Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

  3. vascular density 6 month after dialysis [ Time Frame: 6 month after dialysis ]
    Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

  4. vascular density 12 month after dialysis [ Time Frame: 12 month after dialysis ]
    Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

  5. vascular density before dialysis [ Time Frame: before dialysis ]
    mesure by OCTA

  6. vascular density 1 hour after dialysis [ Time Frame: 1 hour after dialysis ]
    mesure by OCTA

  7. vascular density 1 month after dialysis [ Time Frame: 1 month after dialysis ]
    mesure by OCTA

  8. vascular density 3 month after dialysis [ Time Frame: 3 month after dialysis ]
    mesure by OCTA

  9. vascular density 6 month after dialysis [ Time Frame: 6 month after dialysis ]
    mesure by OCTA

  10. vascular density 12 month after dialysis [ Time Frame: 12 month after dialysis ]
    mesure by OCTA

  11. size of coat retinal optical fibers before dialysis [ Time Frame: before dialysis ]
    variation of the coat

  12. size of coat retinal optical fibers 1 hour after dialysis [ Time Frame: 1 hour after dialysis ]
    variation of the coat

  13. size of coat retinal optical fibers 1 month after dialysis [ Time Frame: 1 month after dialysis ]
    variation of the coat

  14. size of coat retinal optical fibers 3 month after dialysis [ Time Frame: 3 month after dialysis ]
    variation of the coat

  15. size of coat retinal optical fibers 6 month after dialysis [ Time Frame: 6 month after dialysis ]
    variation of the coat

  16. size of coat retinal optical fibers 12 month after dialysis [ Time Frame: 12 month after dialysis ]
    variation of the coat



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients in hemodialysis.
Criteria

Inclusion Criteria:

  • Indication of treatment by hemodialysis
  • First session of dialysis
  • Hemodialysis planned for 1 minimum year

Exclusion Criteria:

  • particular ophthalmological Histories: vitreo-retinal surgery, strong nearsightedness, chronic glaucoma
  • Unaffiliated in a national insurance scheme

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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03804216     History of Changes
Other Study ID Numbers: OCTADIAL
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases