Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
17 april 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
36
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510630
- The First Affiliated Hospital of Jinan University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 72 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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 .
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
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.
|
Using ocular surface analyzer for Inspection
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Non-invasive tear meniscus height
Tidsram: 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
Tidsram: 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
Tidsram: 1year
|
Maximum and minimum of average tear film break-up time in Seconds，higher scores mean a better outcome.
|
1year
|
|
dry eye severity grade
Tidsram: 1year
|
Maximum and minimum of dry eye severity grade，higher scores mean a worse outcome.
|
1year
|
|
tear film lipid layer analysis (distribution and color)
Tidsram: 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
Tidsram: 1year
|
Maximum and minimum of tear film lipid layer thickness grade,higher scores mean a better outcome.
|
1year
|
|
meibomian gland opening blocking site
Tidsram: 1year
|
Maximum and minimum of meibomian gland opening blocking site，higher scores mean a worse outcome.
|
1year
|
|
meibomian gland opening blocking analysis
Tidsram: 1year
|
Maximum and minimum of meibomian gland opening blocking analysis，higher scores mean a worse outcome.
|
1year
|
|
meibomian gland opening secretion oil character score
Tidsram: 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)
Tidsram: 1year
|
Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape)，higher scores mean a worse outcome.
|
1year
|
|
meibomian gland absence area score
Tidsram: 1year
|
Maximum and minimum of meibomian gland absence area score，higher scores mean a worse outcome.
|
1year
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2021
Primärt slutförande (Faktisk)
31 december 2021
Avslutad studie (Faktisk)
31 december 2021
Studieregistreringsdatum
Först inskickad
26 juni 2021
Först inskickad som uppfyllde QC-kriterierna
26 juni 2021
Första postat (Faktisk)
2 juli 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021JN
Plan för individuella deltagardata (IPD)
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