Evaluation of Dry Eye and Meibomian Gland Dysfunction Aft... | NCT01942642

Studies
Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery

NCT01942642

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Sep 16, 2013Estimated

Enrollment

48Actual

Phase

Not provided

Conditions

Meibomian Gland Dysfunction

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Aug 29, 2013

First Submission Date that Met QC Criteria

Sep 13, 2013

First Posted Date

Sep 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2013

Last Update Posted Date

Sep 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular parameters	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Patients scheduled for cataract surgery

Exclusion Criteria:

other comorbid ocular diseases such as ocular allergies.
continuous use of topical ocular medications before surgery
histories of ocular surgery, or ocular injury
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled for cataract surgery

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000080343	Meibomian Gland Dysfunction

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided