Clinical trial NCT04949295: Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
Official title: Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis
Ocular Surface Disease
Dry Eye
OSDI
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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 .

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-invasive tear meniscus height
timeFrame: 1year
measure: first tear film break-up time
timeFrame: 1year
measure: average tear film break-up time
timeFrame: 1year
measure: dry eye severity grade
timeFrame: 1year
measure: tear film lipid layer analysis (distribution and color)
timeFrame: 1year
measure: tear film lipid layer thickness grade
timeFrame: 1year
measure: meibomian gland opening blocking site
timeFrame: 1year
measure: meibomian gland opening blocking analysis
timeFrame: 1year
measure: meibomian gland opening secretion oil character score
timeFrame: 1year
measure: eye redness index analysis (conjunctiva, ciliary shape)
timeFrame: 1year
measure: meibomian gland absence area score
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
References: