Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery

September 13, 2013 updated by: Yonsei University
Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated. The investigators evaluated parameters related with MGD including lid margin abnormalities, meibomian gland expressibility and meibography before and after surgery.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

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

45 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled for cataract surgery

Description

Inclusion Criteria:

1. Patients scheduled for cataract surgery

Exclusion Criteria:

  1. other comorbid ocular diseases such as ocular allergies.
  2. continuous use of topical ocular medications before surgery
  3. histories of ocular surgery, or ocular injury
  4. Already had severe obstructive MGD before surgery, abnormal findings on lid margin (> 3 positive findings), reduced meibum expression (> grade 2), and obstructed gland dropout (meibography score > 3)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular parameters
Time Frame: change of Ocular parameters from 1 to 3 months after cataract surgery
Ocular symptom score, lid margin abnormalities, superficial punctuate keratopathy, tear film break-up time, Shirmer's test, lower tear meniscus height (TMH), depth (TMD), and area (TMA), meibum expressibility, and meibography score
change of Ocular parameters from 1 to 3 months after cataract surgery

Collaborators and Investigators

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

Sponsor

Yonsei University

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

November 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 13, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0690

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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