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Changes of Keratometric Value and Ocular Aberration After Treatment of Meibomian Gland Dysfunction

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692665
First Posted: September 25, 2012
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
Ocular aberration may play a role in determining optical quality. Recently performed study reported that ocular aberration of preocular tear film would be important factor in not only diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this study, the investigators will aim to prove the improvement of quality of vision via ocular aberration changes indirectly after the proper treatment for moderate and severe meibomian gland dysfunction. Also, the investigators will evaluate the changes of keratometric values after treatment for moderate and severe meibomian gland dysfunction, which could be demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.

Condition
Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Changes of keratometric value and ocular aberration [ Time Frame: a minimum of four minutes, once or twice dailybefore treatment, after 1 month, and after 2 months of treatment ]

Enrollment: 0
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
stage 3 or stage 4 meibomiang gland dysfunction patients
stage 3 or stage 4 meibomiang gland dysfunction patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
stage 3 or stage 4 meibomiang gland dysfunction patients
Criteria

Inclusion Criteria:

(1) stage 3 or 4 meibomian gland dysfunction

Exclusion Criteria:

  1. history of previous ocular or intraocular surgery
  2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
  3. history of intolerance or hypersensitivity to any component of the study medications,
  4. wearing contact lenses during the study period, presence of current punctal occlusion,
  5. pregnancy, lactating women, and children.
  6. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01692665     History of Changes
Other Study ID Numbers: 1-2012-0031
First Submitted: September 16, 2012
First Posted: September 25, 2012
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
meibomian gland dysfunction
keratometric value
ocular aberration