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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02411487
Other study ID # 4-2014-1103
Secondary ID
Status Completed
Phase N/A
First received March 5, 2015
Last updated January 23, 2017
Start date March 16, 2015
Est. completion date August 3, 2015

Study information

Verified date January 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 3, 2015
Est. primary completion date August 3, 2015
Accepts healthy volunteers No
Gender All
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Department of Ophthalmology Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary ocular surface staining 1 month after cataract surgery
Primary tear film break-up time, 1 month after cataract surgery
Primary conjunctival injection, 1 month after cataract surgery
Primary Schirmer's test I 1 month after cataract surgery
Primary ocular surface disease index 1 month after cataract surgery
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