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

Renal Failure Clinical Trial

— OCTADIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804216
• Other study ID #: OCTADIAL
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Ophtalmology department	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular density before hemodialysis	Analysis of the variation of the vascular densities in retinal macula in the central 6 mm	before hemodialysis
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	vascular density before dialysis	mesure by OCTA	before dialysis
Secondary	vascular density 1 hour after dialysis	mesure by OCTA	1 hour after dialysis
Secondary	vascular density 1 month after dialysis	mesure by OCTA	1 month after dialysis
Secondary	vascular density 3 month after dialysis	mesure by OCTA	3 month after dialysis
Secondary	vascular density 6 month after dialysis	mesure by OCTA	6 month after dialysis
Secondary	vascular density 12 month after dialysis	mesure by OCTA	12 month after dialysis
Secondary	size of coat retinal optical fibers before dialysis	variation of the coat	before dialysis
Secondary	size of coat retinal optical fibers 1 hour after dialysis	variation of the coat	1 hour after dialysis
Secondary	size of coat retinal optical fibers 1 month after dialysis	variation of the coat	1 month after dialysis
Secondary	size of coat retinal optical fibers 3 month after dialysis	variation of the coat	3 month after dialysis
Secondary	size of coat retinal optical fibers 6 month after dialysis	variation of the coat	6 month after dialysis
Secondary	size of coat retinal optical fibers 12 month after dialysis	variation of the coat	12 month after dialysis