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

NCT03804216 | Completed

• 1 other identifier: OCTADIAL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• vascular density 1 month after dialysis

  1 month after dialysis

• vascular density 3 month after dialysis

  3 month after dialysis

• vascular density 6 month after dialysis

  6 month after dialysis

• vascular density 12 month after dialysis

  12 month after dialysis

• vascular density before dialysis

  before dialysis

Interventions

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

Also known as: SD-OCT and OCT Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients in hemodialysis.

You may qualify if:

• Indication of treatment by hemodialysis
• First session of dialysis
• Hemodialysis planned for 1 minimum year

You may not qualify if:

• particular ophthalmological Histories: vitreo-retinal surgery, strong nearsightedness, chronic glaucoma
• Unaffiliated in a national insurance scheme

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Ophtalmology department

Créteil, 94000, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: January 1, 2019
• Primary Completion: February 26, 2019
• Study Completion: June 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

FR (1)