Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

Dry Eye Clinical Trial

Official title:

Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949295
• Other study ID #: 2021JN
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital of Jinan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Hemodialysis
• Ocular Surface Disease
• OSDI

Intervention

Device:
• ocular surface analyzer
Using ocular surface analyzer for Inspection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
XiaoYong Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive tear meniscus height	Maximum and minimum of Non-invasive tear meniscus height in millimetre,higher scores mean a better outcome.	1year
Primary	first tear film break-up time	Maximum and minimum of first tear film break-up time in Seconds,higher scores mean a better outcome.	1year
Primary	average tear film break-up time	Maximum and minimum of average tear film break-up time in Seconds,higher scores mean a better outcome.	1year
Primary	dry eye severity grade	Maximum and minimum of dry eye severity grade,higher scores mean a worse outcome.	1year
Primary	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.	1year
Primary	tear film lipid layer thickness grade	Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.	1year
Primary	meibomian gland opening blocking site	Maximum and minimum of meibomian gland opening blocking site,higher scores mean a worse outcome.	1year
Primary	meibomian gland opening blocking analysis	Maximum and minimum of meibomian gland opening blocking analysis,higher scores mean a worse outcome.	1year
Primary	meibomian gland opening secretion oil character score	Maximum and minimum of meibomian gland opening secretion oil character score,higher scores mean a worse outcome.	1year
Primary	eye redness index analysis (conjunctiva, ciliary shape)	Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape),higher scores mean a worse outcome.	1year
Primary	meibomian gland absence area score	Maximum and minimum of meibomian gland absence area score,higher scores mean a worse outcome.	1year