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Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function

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ClinicalTrials.gov Identifier: NCT04667871
Recruitment Status : Withdrawn (An six-month follow-up was completed after the treatment)
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Yune Zhao, Wenzhou Medical University

Study Description
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Brief Summary:
50 participants at Eye Hospital of Wenzhou Medical University during August, 2017 to July, 2020 will be enrolled in this study. To study the effect of cataract supermammary surgery on the morphology and function of meibomian glands

Condition or disease Intervention/treatment
Meibomian Gland Dysfunction Procedure: cataract surgery

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
Eyes for cataract surgery
Eyes for cataract surgery
 Procedure: cataract surgery
Eyes for cataract surgery
Eyes without cataract surgery
Eyes without cataract surgery


Outcome Measures
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Primary Outcome Measures :
  1. OSDI scale survey [ Time Frame: 08/2017 to 07/2020 ]
    OSDI scale survey

  2. tear meniscus height（mm） [ Time Frame: 08/2017 to 07/2020 ]
    tear meniscus height（mm）

  3. first tear film rupture time（s） [ Time Frame: 08/2017 to 07/2020 ]
    first tear film rupture time（s）

  4. average tear film rupture time（s） [ Time Frame: 08/2017 to 07/2020 ]
    average tear film rupture time（s）

  5. the range of meibomian gland missing（%） [ Time Frame: 08/2017 to 07/2020 ]
    the range of meibomian gland missing（%）

  6. meibomian gland average diameter (mm) [ Time Frame: 08/2017 to 07/2020 ]
    meibomian gland average diameter (mm)

  7. meibomian gland length (mm) [ Time Frame: 08/2017 to 07/2020 ]
    meibomian gland length (mm)

  8. meibomian gland area (mm^2) [ Time Frame: 08/2017 to 07/2020 ]
    meibomian gland area (mm^2)

  9. meibomian gland deformation coefficient [ Time Frame: 08/2017 to 07/2020 ]
    meibomian gland deformation coefficient

  10. meibomian gland total proportion of glands (%) [ Time Frame: 08/2017 to 07/2020 ]
    meibomian gland total proportion of glands (%)

  11. meibomian gland imaging value [ Time Frame: 08/2017 to 07/2020 ]
    meibomian gland imaging value


Eligibility Criteria
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Ages Eligible for Study:   38 Years to 87 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those patients who undergoing cataract hyperemulsification surgery and previously untreated with xerophthalmia.
Criteria

Inclusion Criteria:

  • Previously untreated patients with xerophthalmia
  • Undergoing cataract hyperemulsification surgery

Exclusion Criteria:

  • No history of ocular surgery and trauma
  • Any eye diseases except xerophthalmia
  • No treated for xerophthalmia before
  • Successful completion of follow-ups
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04667871    
Other Study ID Numbers: XZZ-meibomian gland
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yune Zhao, Wenzhou Medical University:
meibomian gland
cataract surgery
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases