Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery

Meibomian Gland Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942642
• Other study ID #: 4-2012-0690
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: September 13, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: September 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 88 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No