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

Completed

• Conditions: Renal Failure

• Registration Number: NCT03804216
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Primary Completion: 2019-02-26
• Study Completion: 2020-06-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vascular density before hemodialysis	before hemodialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm
vascular density 1 hour after hemodialysis	1 hour after hemodialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm

Secondary Outcome Measures

Name	Time	Method
vascular density 1 hour after dialysis	1 hour after dialysis	mesure by OCTA
size of coat retinal optical fibers 12 month after dialysis	12 month after dialysis	variation of the coat
size of coat retinal optical fibers before dialysis	before dialysis	variation of the coat
size of coat retinal optical fibers 1 month after dialysis	1 month after dialysis	variation of the coat
size of coat retinal optical fibers 3 month after dialysis	3 month after dialysis	variation of the coat
size of coat retinal optical fibers 6 month after dialysis	6 month after dialysis	variation of the coat
vascular density 1 month after dialysis	1 month after dialysis	mesure by OCTA
vascular density 3 month after dialysis	3 month after dialysis	mesure by OCTA
vascular density before dialysis	before dialysis	mesure by OCTA
vascular density 6 month after dialysis	6 month after dialysis	mesure by OCTA
vascular density 12 month after dialysis	12 month after dialysis	mesure by OCTA
size of coat retinal optical fibers 1 hour after dialysis	1 hour after dialysis	variation of the coat

Trial Locations

Locations (1)

Ophtalmology department; 🇫🇷 Creteil, France