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Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

17. april 2022 opdateret af: XiaoYong Liu
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

36

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510630
        • The First Affiliated Hospital of Jinan University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 72 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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 .

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: ocular surface analyzer
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.
Enhed: ocular surface analyzer
Using ocular surface analyzer for Inspection

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

XiaoYong Liu

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2021

Primær færdiggørelse (Faktiske)

31. december 2021

Studieafslutning (Faktiske)

31. december 2021

Datoer for studieregistrering

Først indsendt

26. juni 2021

Først indsendt, der opfyldte QC-kriterier

26. juni 2021

Først opslået (Faktiske)

2. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021JN

Plan for individuelle deltagerdata (IPD)

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