Clinical trial NCT03804216: Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients
Official title: Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in hemodialysis.

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).


Eligibility 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

Primary outcomes:
measure: vascular density before hemodialysis
timeFrame: before hemodialysis
measure: vascular density 1 hour after hemodialysis
timeFrame: 1 hour after hemodialysis
Secondary outcomes:
measure: vascular density 1 month after dialysis
timeFrame: 1 month after dialysis
measure: vascular density 3 month after dialysis
timeFrame: 3 month after dialysis
measure: vascular density 6 month after dialysis
timeFrame: 6 month after dialysis
measure: vascular density 12 month after dialysis
timeFrame: 12 month after dialysis
measure: vascular density before dialysis
timeFrame: before dialysis
measure: vascular density 1 hour after dialysis
timeFrame: 1 hour after dialysis
measure: vascular density 1 month after dialysis
timeFrame: 1 month after dialysis
measure: vascular density 3 month after dialysis
timeFrame: 3 month after dialysis
measure: vascular density 6 month after dialysis
timeFrame: 6 month after dialysis
measure: vascular density 12 month after dialysis
timeFrame: 12 month after dialysis
measure: size of coat retinal optical fibers before dialysis
timeFrame: before dialysis
measure: size of coat retinal optical fibers 1 hour after dialysis
timeFrame: 1 hour after dialysis
measure: size of coat retinal optical fibers 1 month after dialysis
timeFrame: 1 month after dialysis
measure: size of coat retinal optical fibers 3 month after dialysis
timeFrame: 3 month after dialysis
measure: size of coat retinal optical fibers 6 month after dialysis
timeFrame: 6 month after dialysis
measure: size of coat retinal optical fibers 12 month after dialysis
timeFrame: 12 month after dialysis
Other outcomes:
Locations:
city: Creteil
country: France
facility: Ophtalmology department
Study officials:
References: