Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)NCT01692665
Changes of Keratometric Value and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
An observational study of Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction), run by Yonsei University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stage 3 or stage 4 meibomiang gland dysfunction patients
Who may be able to join
- stage 3 or 4 meibomian gland dysfunction
Who cannot join
- history of previous ocular or intraocular surgery
- ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
- history of intolerance or hypersensitivity to any component of the study medications,
- wearing contact lenses during the study period, presence of current punctal occlusion,
- pregnancy, lactating women, and children.
- 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
About this study
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.
- Conditions
- Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)
- Keywords
- meibomian gland dysfunction, keratometric value, ocular aberration
- Medical subject headings
- Lymphoma, Follicular, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stage 3 or stage 4 meibomiang gland dysfunction patients | stage 3 or stage 4 meibomiang gland dysfunction patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of keratometric value and ocular aberration
Measured: a minimum of four minutes, once or twice dailybefore treatment, after 1 month, and after 2 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692665
- Sponsor's protocol ID
- 1-2012-0031
- Status last verified
- Feb 2014
- First submitted
- 16 Sep 2012
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Keratometric Value and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT01692665
- Acronym / sponsor ID
- 1-2012-0031
- Conditions
- Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)
- Keywords
- meibomian gland dysfunction, keratometric value, ocular aberration
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stage 3 or stage 4 meibomiang gland dysfunction patients | – | –stage 3 or stage 4 meibomiang gland dysfunction patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage 3 or stage 4 meibomiang gland dysfunction patients
Key inclusion criteria (1 listed)
- stage 3 or 4 meibomian gland dysfunction
Key exclusion criteria (6 listed)
- history of previous ocular or intraocular surgery
- ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,
- history of intolerance or hypersensitivity to any component of the study medications,
- wearing contact lenses during the study period, presence of current punctal occlusion,
- pregnancy, lactating women, and children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction), run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.