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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434145
• Other study ID #: 2016-05-005
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 8, 2018
• Start date: September 9, 2016
• Est. completion date: December 29, 2017

Study information

• Verified date: February 2018
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 29, 2017
• Est. primary completion date: September 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hemolysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of retinal and choroidal thickness after hemodialysis	retinal & choroidal thickness on OCT	immediately (within 10 minutes) before and after hemodialysis
Secondary	changes of foveal vascular density using optical coherence tomography-angiography (OCTA) after hemodialysis	vessel density on OCTA	immediately (within 10 minutes) before and after hemodialysis
Secondary	the effect of hemodialysis (HD) on anterior chamber angle by anterior segment optical coherence	intraocular pressure, retinal thickness, anterior chamber angle	immediately (within 10 minutes) before and after hemodialysis