NCT03434145

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

February 5, 2018

Last Update Submit

February 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • changes of retinal and choroidal thickness after hemodialysis

    retinal \& choroidal thickness on OCT

    immediately (within 10 minutes) before and after hemodialysis

Secondary Outcomes (2)

  • changes of foveal vascular density using optical coherence tomography-angiography (OCTA) after hemodialysis

    immediately (within 10 minutes) before and after hemodialysis

  • the effect of hemodialysis (HD) on anterior chamber angle by anterior segment optical coherence

    immediately (within 10 minutes) before and after hemodialysis

Study Arms (1)

patients with chronic kidney diseases

patients with end stage retinal disease undergoing hemodialysis underwent various ophthalmologic exams before and after hemodialysis.

Other: ophthalmologic exams

Interventions

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

patients with chronic kidney diseases

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with end-stage renal disease who undergoing hemodialysis

You may qualify if:

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

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicHemolysis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Heeyoon Cho, MD

    Hanyang University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 15, 2018

Study Start

September 9, 2016

Primary Completion

September 7, 2017

Study Completion

December 29, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share