Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function

December 14, 2020 updated by: Yune Zhao
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eyes for cataract surgery
Procedure: cataract surgery
Eyes for cataract surgery
Eyes without cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSDI scale survey
Time Frame: 08/2017 to 07/2020
OSDI scale survey
08/2017 to 07/2020
tear meniscus height（mm）
Time Frame: 08/2017 to 07/2020
tear meniscus height（mm）
08/2017 to 07/2020
first tear film rupture time（s）
Time Frame: 08/2017 to 07/2020
first tear film rupture time（s）
08/2017 to 07/2020
average tear film rupture time（s）
Time Frame: 08/2017 to 07/2020
average tear film rupture time（s）
08/2017 to 07/2020
the range of meibomian gland missing（%）
Time Frame: 08/2017 to 07/2020
the range of meibomian gland missing（%）
08/2017 to 07/2020
meibomian gland average diameter (mm)
Time Frame: 08/2017 to 07/2020
meibomian gland average diameter (mm)
08/2017 to 07/2020
meibomian gland length (mm)
Time Frame: 08/2017 to 07/2020
meibomian gland length (mm)
08/2017 to 07/2020
meibomian gland area (mm^2)
Time Frame: 08/2017 to 07/2020
meibomian gland area (mm^2)
08/2017 to 07/2020
meibomian gland deformation coefficient
Time Frame: 08/2017 to 07/2020
meibomian gland deformation coefficient
08/2017 to 07/2020
meibomian gland total proportion of glands (%)
Time Frame: 08/2017 to 07/2020
meibomian gland total proportion of glands (%)
08/2017 to 07/2020
meibomian gland imaging value
Time Frame: 08/2017 to 07/2020
meibomian gland imaging value
08/2017 to 07/2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yune Zhao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

October 4, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XZZ-meibomian gland

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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