NCT02567565

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

October 1, 2015

Last Update Submit

October 1, 2015

Conditions

Cataract Patients

Outcome Measures

Primary Outcomes (1)

  • tear film lipid layer thickness

    tear film lipid layer thickness measured by LipiView interferometer

    3-month after phacoemulsification

Study Arms (1)

cataract patients

cataract patients undergoing phacoemulsification

Other: LipiView

Interventions

LipiViewOTHER

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

cataract patients

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cataract patients with lens opacities classification higher than grade III

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Yonsei University College of Medicine

Seoul, Seoul, 03722, South Korea

Location

Study Officials

  • Tae-im Kim, MD, Ph.D

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 5, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations

KR(1)