Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

NCT04949295 | Completed DMC

• 1 other identifier: 2021JN
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Ocular Surface Disease; Dry Eye; OSDI

Outcome Measures

Primary Outcomes (11)

• Non-invasive tear meniscus height

  Maximum and minimum of Non-invasive tear meniscus height in millimetre，higher scores mean a better outcome.

  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.

  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.

  1year

• dry eye severity grade

  Maximum and minimum of dry eye severity grade，higher scores mean a worse outcome.

  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.

  1year

• tear film lipid layer thickness grade

  Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.

  1year

• meibomian gland opening blocking site

  Maximum and minimum of meibomian gland opening blocking site，higher scores mean a worse outcome.

  1year

• meibomian gland opening blocking analysis

  Maximum and minimum of meibomian gland opening blocking analysis，higher scores mean a worse outcome.

  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.

  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.

  1year

• meibomian gland absence area score

  Maximum and minimum of meibomian gland absence area score，higher scores mean a worse outcome.

  1year

Study Arms (2)

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.

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.

Device: ocular surface analyzer

Interventions

ocular surface analyzer DEVICE

Using ocular surface analyzer for Inspection

the hemodialysis group; the normal group

Eligibility Criteria

• Age: 25 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• XiaoYong Liu: lead

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 2, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CN (1)