Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function

Sponsor
Yune Zhao (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04667871
Collaborator
(none)
0
37

Study Details

Study Description

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 Phase
  • Procedure: cataract surgery

Study Design

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 :
Aug 1, 2017
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. OSDI scale survey [08/2017 to 07/2020]

    OSDI scale survey

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

    tear meniscus height(mm)

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

    first tear film rupture time(s)

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

    average tear film rupture time(s)

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

    the range of meibomian gland missing(%)

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

    meibomian gland average diameter (mm)

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

    meibomian gland length (mm)

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

    meibomian gland area (mm^2)

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

    meibomian gland deformation coefficient

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

    meibomian gland total proportion of glands (%)

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

    meibomian gland imaging value

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 87 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Yune Zhao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Dec 16, 2020
Last Update Posted:
Dec 16, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2020