Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

NCT ID: NCT04949295

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

Hemodialysis; Ocular Surface Disease; Dry Eye; OSDI

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ocular surface analyzer

Intervention Type: DEVICE

Using ocular surface analyzer for Inspection

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.

ocular surface analyzer

Intervention Type: DEVICE

Using ocular surface analyzer for Inspection

Interventions

ocular surface analyzer

Using ocular surface analyzer for Inspection

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Older than 18
• Hemodialysis patient
• The subject understands the purpose of this clinical trial and agrees to sign an informed consent form.

• 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.

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.

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

XiaoYong Liu

OTHER

Sponsor Role: lead

Responsible Party

XiaoYong Liu

Deputy chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2021JN

Identifier Type: -

Identifier Source: org_study_id