CataractNCT02411487
Meibomian Gland Dysfunction (MGD) and Tear Cytokines After Cataract Surgery According to Preoperative Meibomian Gland Status
An observational study of Cataract, run by Yonsei University at 1 site in South Korea.
Trial summary
To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative MGD grade. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Cataract
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2015to 3 Aug 2015
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 55 eyes from 55 patients who underwent cataract surgery were included.
Who may be able to join
- males or non-pregnant females aged between 55 to 80 years-old.
Who cannot join
- had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, as well as patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative MGD grade.
- Conditions
- Cataract
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory tear cytokine concentration
comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay
Measured: 1 month after cataract surgery
ocular surface staining
Measured: 1 month after cataract surgery
tear film break-up time,
Measured: 1 month after cataract surgery
conjunctival injection,
Measured: 1 month after cataract surgery
Schirmer's test I
Measured: 1 month after cataract surgery
ocular surface disease index
Measured: 1 month after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start16 Mar 2015
- Primary completion3 Aug 2015
- Study completion3 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- 50 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
- NCT02411487
- Sponsor's protocol ID
- 4-2014-1103
- Status last verified
- Jan 2017
- First submitted
- 5 Mar 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Li XM, Hu L, Hu J, Wang W. Investigation of dry eye disease and analysis of the pathogenic factors in patients after cataract surgery. Cornea. 2007 Oct;26(9 Suppl 1):S16-20. doi: 10.1097/ICO.0b013e31812f67ca.
PubMed 17881910Cyclin-dependent kinase inhibitory protein expression in human choroidal melanoma tumors. Mouriaux F,*(1) Maurage CA, Labalette P, Sablonniere B, Malecaze F, Darbon JM. Inv Ophthalmol Vis Sci 2000;41:2837-2843. Am J Ophthalmol. 2001 Jan;131(1):157. doi: 10.1016/s0002-9394(00)00922-3. No abstract available.
PubMed 11341889
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meibomian Gland Dysfunction (MGD) and Tear Cytokines After Cataract Surgery According to Preoperative Meibomian Gland Status
- ClinicalTrials.gov ID
- NCT02411487
- Acronym / sponsor ID
- 4-2014-1103
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 3 Aug 2015 (actual)
- First posted
- 8 Apr 2015 (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.
To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative MGD grade.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 55 eyes from 55 patients who underwent cataract surgery were included.
Key inclusion criteria (1 listed)
- males or non-pregnant females aged between 55 to 80 years-old.
Key exclusion criteria (1 listed)
- had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, as well as patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
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
inflammatory tear cytokine concentration
Time frame: 1 month after cataract surgery
comparison of tear cytokines (IL-2,4,10,17a, INF-r, TNF-a) concentrations in patients with or without newly diagnosed chronic GVHD after SCT using a multiplex immunobead assay
ocular surface staining
Time frame: 1 month after cataract surgery
tear film break-up time,
Time frame: 1 month after cataract surgery
conjunctival injection,
Time frame: 1 month after cataract surgery
Schirmer's test I
Time frame: 1 month after cataract surgery
ocular surface disease index
Time frame: 1 month after cataract surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Background: PubMed 17881910Li XM, Hu L, Hu J, Wang W. Investigation of dry eye disease and analysis of the pathogenic factors in patients after cataract surgery. Cornea. 2007 Oct;26(9 Suppl 1):S16-20. doi: 10.1097/ICO.0b013e31812f67ca.
- Background: PubMed 11341889Cyclin-dependent kinase inhibitory protein expression in human choroidal melanoma tumors. Mouriaux F,*(1) Maurage CA, Labalette P, Sablonniere B, Malecaze F, Darbon JM. Inv Ophthalmol Vis Sci 2000;41:2837-2843. Am J Ophthalmol. 2001 Jan;131(1):157. doi: 10.1016/s0002-9394(00)00922-3. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Yonsei University at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
inflammatory tear cytokine concentration (time frame: 1 month after cataract surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411487, which also lists 2 linked publications.
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 25 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.