Chronic Kidney DiseasesNCT03434145
Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
An observational study of Chronic Kidney Diseases and Hemolysis, run by Hanyang University.
Trial summary
To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Hemolysis
- What is being tested?
- ophthalmologic exams
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2016to 29 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with end-stage renal disease who undergoing hemodialysis
Who may be able to join
- 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
Who cannot join
- 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.
About this study
To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD).
Read the 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.
- Conditions
- Chronic Kidney Diseases, Hemolysis
- Being tested
- ophthalmologic exams
- Medical subject headings
- Renal Insufficiency, Chronic, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmologic examsOther
ophthalmologic exams such as vision, intraocular pressure, axial length and optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic kidney diseases | patients with end stage retinal disease undergoing hemodialysis underwent various ophthalmologic exams before and after hemodialysis. Receives: Other: ophthalmologic exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of retinal and choroidal thickness after hemodialysis
retinal \& choroidal thickness on OCT
Measured: immediately (within 10 minutes) before and after hemodialysis
Secondary outcomes (2)
changes of foveal vascular density using optical coherence tomography-angiography (OCTA) after hemodialysis
vessel density on OCTA
Measured: immediately (within 10 minutes) before and after hemodialysis
the effect of hemodialysis (HD) on anterior chamber angle by anterior segment optical coherence
intraocular pressure, retinal thickness, anterior chamber angle
Measured: immediately (within 10 minutes) before and after hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start9 Sep 2016
- Primary completion7 Sep 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Un shin, Hanyang University
- Investigators
- Heeyoon Cho, MD, Study chair, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434145
- Sponsor's protocol ID
- 2016-05-005
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT03434145
- Acronym / sponsor ID
- 2016-05-005
- Conditions
- Chronic Kidney Diseases, Hemolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (ESRD).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with chronic kidney diseases | – | Other: ophthalmologic examspatients with end stage retinal disease undergoing hemodialysis underwent various ophthalmologic exams before and after hemodialysis. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end-stage renal disease who undergoing hemodialysis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ophthalmologic examsophthalmologic exams such as vision, intraocular pressure, axial length and optical coherence tomography | Other | patients with chronic kidney diseases |
Primary outcome
changes of retinal and choroidal thickness after hemodialysis
Time frame: immediately (within 10 minutes) before and after hemodialysis
retinal \& choroidal thickness on OCT
2 secondary outcomes
changes of foveal vascular density using optical coherence tomography-angiography (OCTA) after hemodialysis
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heeyoon Cho, MD study chair
Hanyang University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Hemolysis, run by Hanyang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of retinal and choroidal thickness after hemodialysis (time frame: immediately (within 10 minutes) before and after hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.