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

February 8, 2018 updated by: Yong Un shin, Hanyang University
To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with end-stage renal disease who undergoing hemodialysis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of retinal and choroidal thickness after hemodialysis
Time Frame: immediately (within 10 minutes) before and after hemodialysis
retinal & choroidal thickness on OCT
immediately (within 10 minutes) before and after hemodialysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately (within 10 minutes) before and after hemodialysis
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
immediately (within 10 minutes) before and after hemodialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Investigators

  • Study Chair: Heeyoon Cho, MD, Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2016

Primary Completion (Actual)

September 7, 2017

Study Completion (Actual)

December 29, 2017

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-05-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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