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

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).

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Other: Multimodal Imaging Analysis

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94000
    • Ophtalmology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients in hemodialysis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vascular density before hemodialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	before hemodialysis
vascular density 1 hour after hemodialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	1 hour after hemodialysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vascular density 1 month after dialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	1 month after dialysis
vascular density 3 month after dialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	3 month after dialysis
vascular density 6 month after dialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	6 month after dialysis
vascular density 12 month after dialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	12 month after dialysis
vascular density before dialysis	mesure by OCTA	before dialysis
vascular density 1 hour after dialysis	mesure by OCTA	1 hour after dialysis
vascular density 1 month after dialysis	mesure by OCTA	1 month after dialysis
vascular density 3 month after dialysis	mesure by OCTA	3 month after dialysis
vascular density 6 month after dialysis	mesure by OCTA	6 month after dialysis
vascular density 12 month after dialysis	mesure by OCTA	12 month after dialysis
size of coat retinal optical fibers before dialysis	variation of the coat	before dialysis
size of coat retinal optical fibers 1 hour after dialysis	variation of the coat	1 hour after dialysis
size of coat retinal optical fibers 1 month after dialysis	variation of the coat	1 month after dialysis
size of coat retinal optical fibers 3 month after dialysis	variation of the coat	3 month after dialysis
size of coat retinal optical fibers 6 month after dialysis	variation of the coat	6 month after dialysis
size of coat retinal optical fibers 12 month after dialysis	variation of the coat	12 month after dialysis

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 26, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: OCTADIAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No