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NCT Number: NCT04949295

Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer

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.

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Key information

Conditions

Hemodialysis Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases OSDI Ocular Surface Disease

Age range

25 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ocular surface analyzer

Device

Using ocular surface analyzer for Inspection

Primary outcomes

  1. Non-invasive tear meniscus height

    Time frame: 1year

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

  2. first tear film break-up time

    Time frame: 1year

    Maximum and minimum of first tear film break-up time in Seconds，higher scores mean a better outcome.

  3. average tear film break-up time

    Time frame: 1year

    Maximum and minimum of average tear film break-up time in Seconds，higher scores mean a better outcome.

  4. dry eye severity grade

    Time frame: 1year

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

  5. tear film lipid layer analysis (distribution and color)

    Time frame: 1year

    Maximum and minimum of tear film lipid layer analysis (distribution and color)，higher scores mean a better outcome.

  6. tear film lipid layer thickness grade

    Time frame: 1year

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

  7. meibomian gland opening blocking site

    Time frame: 1year

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

  8. meibomian gland opening blocking analysis

    Time frame: 1year

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

  9. meibomian gland opening secretion oil character score

    Time frame: 1year

    Maximum and minimum of meibomian gland opening secretion oil character score，higher scores mean a worse outcome.

  10. eye redness index analysis (conjunctiva, ciliary shape)

    Time frame: 1year

    Maximum and minimum of eye redness index analysis (conjunctiva, ciliary shape)，higher scores mean a worse outcome.

  11. meibomian gland absence area score

    Time frame: 1year

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

Sponsors and collaborators

Lead sponsor

XiaoYong Liu

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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