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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03434145
Other study ID # 2016-05-005
Secondary ID
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
Health authority
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.

Study Design


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
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