NCT04667871

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

December 16, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

October 4, 2020

Last Update Submit

December 14, 2020

Conditions

Keywords

meibomian glandcataract surgery

Outcome Measures

Primary Outcomes (11)

  • OSDI scale survey

    OSDI scale survey

    08/2017 to 07/2020

  • tear meniscus height(mm)

    tear meniscus height(mm)

    08/2017 to 07/2020

  • first tear film rupture time(s)

    first tear film rupture time(s)

    08/2017 to 07/2020

  • average tear film rupture time(s)

    average tear film rupture time(s)

    08/2017 to 07/2020

  • the range of meibomian gland missing(%)

    the range of meibomian gland missing(%)

    08/2017 to 07/2020

  • meibomian gland average diameter (mm)

    meibomian gland average diameter (mm)

    08/2017 to 07/2020

  • meibomian gland length (mm)

    meibomian gland length (mm)

    08/2017 to 07/2020

  • meibomian gland area (mm^2)

    meibomian gland area (mm\^2)

    08/2017 to 07/2020

  • meibomian gland deformation coefficient

    meibomian gland deformation coefficient

    08/2017 to 07/2020

  • meibomian gland total proportion of glands (%)

    meibomian gland total proportion of glands (%)

    08/2017 to 07/2020

  • meibomian gland imaging value

    meibomian gland imaging value

    08/2017 to 07/2020

Study Arms (2)

Eyes for cataract surgery

Eyes for cataract surgery

Procedure: cataract surgery

Eyes without cataract surgery

Eyes without cataract surgery

Interventions

Eyes for cataract surgery

Eyes for cataract surgery

Eligibility Criteria

Age38 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those patients who undergoing cataract hyperemulsification surgery and previously untreated with xerophthalmia.

You may qualify if:

  • Previously untreated patients with xerophthalmia
  • Undergoing cataract hyperemulsification surgery

You may not qualify if:

  • No history of ocular surgery and trauma
  • Any eye diseases except xerophthalmia
  • No treated for xerophthalmia before
  • Successful completion of follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

October 4, 2020

First Posted

December 16, 2020

Study Start

August 1, 2017

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

December 16, 2020

Record last verified: 2020-11