NCT02411487

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

March 16, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2015

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

March 5, 2015

Last Update Submit

January 23, 2017

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

    1 month after cataract surgery

  • ocular surface staining

    1 month after cataract surgery

  • tear film break-up time,

    1 month after cataract surgery

  • conjunctival injection,

    1 month after cataract surgery

  • Schirmer's test I

    1 month after cataract surgery

  • ocular surface disease index

    1 month after cataract surgery

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 55 eyes from 55 patients who underwent cataract surgery were included.

You may qualify if:

  • males or non-pregnant females aged between 55 to 80 years-old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 17881910BACKGROUND
  • Cyclin-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.

    PMID: 11341889BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

TEAR

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

April 8, 2015

Study Start

March 16, 2015

Primary Completion

August 3, 2015

Study Completion

August 3, 2015

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations