NCT01016405

Brief Summary

This study will determine the incidence and severity of dry eye in patients undergoing cataract surgery as determined by grade on the International Task Force (ITF) scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

1.3 years

First QC Date

July 13, 2009

Last Update Submit

January 31, 2011

Conditions

Dry Eye

Keywords

Dry eyeincidence and severitycataract surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.

    One study visit

Secondary Outcomes (1)

  • TBUT (tear break-up time), OSDI (Ocular surface disease index), corneal staining with fluorescein, conjunctival staining with lissamine, Schirmer's, and a patient questionnaire. These are all standard operations of care.

    One study visit

Study Arms (1)

Severity of dry eye in patients undergoing cataract surgery

Eligibility Criteria

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

Primary care clinic.

You may qualify if:

  • Patients should be at least 55 years old.
  • Patients must be scheduled to undergo cataract surgery.

You may not qualify if:

  • No previous intraocular surgery in the previous 3 months in either eye.
  • No previous Corneal laser vision correction in either eye within the last one year.
  • No previous lid surgery within the past 3 months.
  • Patients may not have used topical antibiotics, topical NSAIDs or topical steroid in either eye in the past month.
  • Patients are not eligible if they have recently been started on Restasis solely as a perioperative treatment regimen.
  • Patients presently using Restasis in either eye will not undergo any of the study testing but a questionnaire should be completed for these patients regarding use of these medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Excellence in Eye Care

Miami, Florida, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • William Trattler, MD

    The Center for Excellence in Eye Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2009

First Posted

November 19, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

US(1)