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Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434145
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Yong Un shin, Hanyang University

Study Description
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Brief Summary:
To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD).

Condition or disease Intervention/treatment
Chronic Kidney Diseases Hemolysis Other: ophthalmologic exams

Detailed Description:

Subjects: patients with ESRD undergoing hemodialysis at the Dialysis Center of Hanyang Guri Hospital

Ocular parameters: visual acuity, intraocular pressure, axial length, OCT Other systemic parameters: body weight, ultrafiltration volume, and systolic/diastolic blood pressure

All measurements were performed near the dialysis center. Measurements were performed on Monday (for patients who underwent dialysis sessions on Monday, Wednesday, and Friday) or Tuesday (for patients who underwent dialysis sessions on Tuesday, Thursday, and Saturday.

All parameters were measured before and after the hemodialysis.

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
patients with chronic kidney diseases
patients with end stage retinal disease undergoing hemodialysis underwent various ophthalmologic exams before and after hemodialysis.
 Other: ophthalmologic exams
ophthalmologic exams such as vision, intraocular pressure, axial length and optical coherence tomography


Outcome Measures
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Primary Outcome Measures :
  1. changes of retinal and choroidal thickness after hemodialysis [ Time Frame: immediately (within 10 minutes) before and after hemodialysis ]
    retinal & choroidal thickness on OCT


Secondary Outcome Measures :
  1. changes of foveal vascular density using optical coherence tomography-angiography (OCTA) after hemodialysis [ Time Frame: immediately (within 10 minutes) before and after hemodialysis ]
    vessel density on OCTA

  2. the effect of hemodialysis (HD) on anterior chamber angle by anterior segment optical coherence [ Time Frame: immediately (within 10 minutes) before and after hemodialysis ]
    intraocular pressure, retinal thickness, anterior chamber angle


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with end-stage renal disease who undergoing hemodialysis
Criteria

Inclusion Criteria:

  • 1) patients who are regularly dialyzed in our dialysis room to participate in the study
  • 2) patients who agree with our study protocol
  • 3) patients who have unstable general condition

Exclusion Criteria:

  • 1) previous intraocular surgery, (2) baseline IOP greater than 22 mmHg, (3) presence of glaucomatous optic disc changes including excavation, thinning, or notching of the neuroretinal rim, (4) axial length greater than 26 mm, and (5) combined macular and retinal diseases such as central serous chorioretinopathy and age-related macular degeneration, except diabetic retinopathy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434145


Sponsors and Collaborators
Hanyang University
Investigators
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Study Chair: Heeyoon Cho, MD Hanyang University
More Information
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Responsible Party: Yong Un shin, Assistant professor, Hanyang University
ClinicalTrials.gov Identifier: NCT03434145    
Other Study ID Numbers: 2016-05-005
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hemolysis
 Urologic Diseases
Renal Insufficiency
Pathologic Processes