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Completed

NCT Number: NCT03804216

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

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).

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ophtalmology department

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal Imaging Analysis

Other

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 names: SD-OCT and OCT Angiography

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: OCTADIAL

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 15, 2019
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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