Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery

Cataract Patients Clinical Trial

Official title:

Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567565
• Other study ID #: 4-2015-0225
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: October 1, 2015
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the Ocular Surface Disease Index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• cataract patients with lens opacities classification higher than grade III and desire to be spectacle independence for distance and near vision

Exclusion Criteria:

• previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Cataract Patients

Intervention

Other:
• LipiView
tear film lipid layer thickness measured by LipiView interferometer (TearScience Inc, Morrisville, NC)

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear film lipid layer thickness	tear film lipid layer thickness measured by LipiView interferometer	3-month after phacoemulsification	No