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Completed

NCT Number: NCT03434145

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

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemolysis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ophthalmologic exams

Other

ophthalmologic exams such as vision, intraocular pressure, axial length and optical coherence tomography

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2018
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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