HemodialysisNCT04949295
Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
An observational study of Hemodialysis and Ocular Surface Disease, run by XiaoYong Liu at 1 site in China.
Trial summary
We clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients. Read more about this study
- Who is it for?
- Ages 25 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Ocular Surface Disease, Dry Eye
- What is being tested?
- ocular surface analyzer
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 25 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .
the hemodialysis group Inclusion Criteria:
- Older than 18
- Hemodialysis patient
- The subject understands the purpose of this clinical trial and agrees to sign an informed consent form. the hemodialysis group Exclusion Criteria:
- Previous history of ocular trauma or surgery
- History of wearing contact lenses
- Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears
- Eyelid abnormalities (such as eyelid insufficiency, entropion and ECTROPION, tumor, severe trichiasis)
- There have been peritoneal dialysis, kidney transplant surgery patients. the normal group Inclusion Criteria:
- Older than 18
- Healthy people do not have other systemic diseases, such as diabetes and hypertension
- The subject understands the purpose of this clinical trial and agrees to sign an informed consent form. the normal group Exclusion Criteria:
- Previous history of ocular trauma or surgery
- History of wearing contact lenses
- Can Not Stop the use of dry eye caused by drugs and other drugs may directly affect the stability of tear film tears.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
About this study
We clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients. In this study, we examined the ocular surface and analyzed and investigated the characteristics of the ocular surface in hemodialysis patients to provide a basis for ocular surface intervention or treatment in hemodialysis patients before ocular surgery in clinical practice.
Read the detailed description
This study is a clinical case-control study. A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .All the subjects in the hemodialysis group (n = 36, 72 eyes) and the normal group (n = 36, 72 eyes) were investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.
- Conditions
- Hemodialysis, Ocular Surface Disease, Dry Eye, OSDI
- Being tested
- ocular surface analyzer
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocular surface analyzerDevice
Using ocular surface analyzer for Inspection
| Study group | Role | What they receive |
|---|---|---|
| the hemodialysis group | investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded. Receives: Device: ocular surface analyzer | |
| the normal group | investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded. Receives: Device: ocular surface analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear meniscus height
Maximum and minimum of Non-invasive tear meniscus height in millimetre，higher scores mean a better outcome.
Measured: 1year
first tear film break-up time
Maximum and minimum of first tear film break-up time in Seconds，higher scores mean a better outcome.
Measured: 1year
average tear film break-up time
Maximum and minimum of average tear film break-up time in Seconds，higher scores mean a better outcome.
Measured: 1year
dry eye severity grade
Maximum and minimum of dry eye severity grade，higher scores mean a worse outcome.
Measured: 1year
tear film lipid layer analysis (distribution and color)
Maximum and minimum of tear film lipid layer analysis (distribution and color)，higher scores mean a better outcome.
Measured: 1year
tear film lipid layer thickness grade
Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.
Measured: 1year
meibomian gland opening blocking site
Maximum and minimum of meibomian gland opening blocking site，higher scores mean a worse outcome.
Measured: 1year
meibomian gland opening blocking analysis
Maximum and minimum of meibomian gland opening blocking analysis，higher scores mean a worse outcome.
Measured: 1year
meibomian gland opening secretion oil character score
Maximum and minimum of meibomian gland opening secretion oil character score，higher scores mean a worse outcome.
Measured: 1year
eye redness index analysis (conjunctiva, ciliary shape)
Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape)，higher scores mean a worse outcome.
Measured: 1year
meibomian gland absence area score
Maximum and minimum of meibomian gland absence area score，higher scores mean a worse outcome.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- XiaoYong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XiaoYong Liu, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949295
- Sponsor's protocol ID
- 2021JN
- Status last verified
- Apr 2022
- First submitted
- 26 Jun 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
- ClinicalTrials.gov ID
- NCT04949295
- Acronym / sponsor ID
- 2021JN
- Conditions
- Hemodialysis, Ocular Surface Disease, Dry Eye, OSDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- XiaoYong LiuUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Jul 2021 (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.
We clinically observed that some hemodialysis patients had corneal epithelial dryness, shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously affected the effect of surgery, and it is necessary to study the ocular surface characteristics of hemodialysis patients. In this study, we examined the ocular surface and analyzed and investigated the characteristics of the ocular surface in hemodialysis patients to provide a basis for ocular surface intervention or treatment in hemodialysis patients before ocular surgery in clinical practice.
Detailed description
This study is a clinical case-control study. A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .All the subjects in the hemodialysis group (n = 36, 72 eyes) and the normal group (n = 36, 72 eyes) were investigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the hemodialysis group | – | Device: ocular surface analyzerinvestigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded. |
| the normal group | – | Device: ocular surface analyzerinvestigated with the OSDI scale, and then bilateral ocular surface examinations were performed with Keratograph5M eye surface comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film lipid layer analysis (distribution and color), tear film lipid layer thickness grade, meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary shape), and meibomian gland absence area score were recorded. |
Who may qualify
- Ages
- 25 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the Nephrology Department of the First Affiliated Hospital of Jinan University .
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 |
|---|---|---|
| ocular surface analyzerUsing ocular surface analyzer for Inspection | Device | the hemodialysis group, the normal group |
Primary outcome
Non-invasive tear meniscus height
Time frame: 1year
Maximum and minimum of Non-invasive tear meniscus height in millimetre，higher scores mean a better outcome.
first tear film break-up time
Time frame: 1year
Maximum and minimum of first tear film break-up time in Seconds，higher scores mean a better outcome.
average tear film break-up time
Time frame: 1year
Maximum and minimum of average tear film break-up time in Seconds，higher scores mean a better outcome.
dry eye severity grade
Time frame: 1year
Maximum and minimum of dry eye severity grade，higher scores mean a worse outcome.
tear film lipid layer analysis (distribution and color)
Time frame: 1year
Maximum and minimum of tear film lipid layer analysis (distribution and color)，higher scores mean a better outcome.
tear film lipid layer thickness grade
Time frame: 1year
Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.
meibomian gland opening blocking site
Time frame: 1year
Maximum and minimum of meibomian gland opening blocking site，higher scores mean a worse outcome.
meibomian gland opening blocking analysis
Time frame: 1year
Maximum and minimum of meibomian gland opening blocking analysis，higher scores mean a worse outcome.
meibomian gland opening secretion oil character score
Time frame: 1year
Maximum and minimum of meibomian gland opening secretion oil character score，higher scores mean a worse outcome.
eye redness index analysis (conjunctiva, ciliary shape)
Time frame: 1year
Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape)，higher scores mean a worse outcome.
meibomian gland absence area score
Time frame: 1year
Maximum and minimum of meibomian gland absence area score，higher scores mean a worse outcome.
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 19 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis and Ocular Surface Disease, run by XiaoYong Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Non-invasive tear meniscus height (time frame: 1year). The study lists 11 primary outcomes in all. 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 19 Apr 2022.