NCT03276182

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 parameters of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality, meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.

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 not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 5, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
Last Updated

September 8, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

August 29, 2017

Last Update Submit

September 6, 2017

Conditions

Cataract Patients

Outcome Measures

Primary Outcomes (2)

  • the change of parameters associated with dry eye syndrome

    Analysis the change of parameters associated with dry eye syndrome before and after cataract surgery measured by lipiview 2.

    baseline and 1 month after POD(postoperative day)

  • the change of parameters associated with meibomiangland dysfunction

    Analysis the change of parameters associated with meibomiangland dysfunction before and after cataract surgery measured by lipiview 2.

    baseline and 1 month after POD(postoperative day)

Study Arms (1)

cataract patients

EXPERIMENTAL

cataract patients undergoing phacoemulsification

Device: Lipiview 2

Interventions

Lipiview 2DEVICE

Tear film lipid layer thickness and meibomian gland dropout were 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+)

You may qualify if:

  • Patients with cataract surgery planning with phacoemulsification and intraocular lens implantation with or without mild dry eye syndrome

You may not qualify if:

  • the previous use of eye drops, except artificial tears within 3 months before cataract surgery
  • a history of previous ocular surgery or trauma
  • the presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema, and any surgical complications including rupture of the posterior capsule during cataract surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 8, 2017

Study Start

October 5, 2015

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

September 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)