NCT01471561

Brief Summary

This is a retrospective study to determine if rates of osmolarity and dry eye disease symptoms increase following cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

November 10, 2011

Last Update Submit

February 2, 2016

Conditions

Cataract

Keywords

OsmolarityCataractDry Eye

Outcome Measures

Primary Outcomes (1)

  • Post surgical tear osmolarity

    Correlation between pre-surgery value and development of dry eye disease post surgery 1\) Comparison of Osmolarity measurement pre to post-op, as well as over time, to determine change and statistical significance

    90-Day post-surgical

Secondary Outcomes (1)

  • Post-surgical dry eye symptoms

    90-Day post-surgical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Male or female, eighteen years of age or older 2. Confirmed diagnosis of cataract with cataract surgery performed in at least one eye

You may qualify if:

  • Male or female, eighteen years of age or older
  • Confirmed diagnosis of cataract with cataract surgery performed in at least one eye

You may not qualify if:

  • \. Any complications of cataract surgery that have required a sclera incision rather than a clear corneal incision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

William Trattler, MD

Miami, Florida, 33176, United States

Location

David Hardten, MD

Minneapolis, Minnesota, 55404, United States

Location

Chris Starr, MD

New York, New York, 10021, United States

Location

Eric Donnenfeld, MD

Rockville Centre, New York, 11570, United States

Location

MeSH Terms

Conditions

CataractDry Eye Syndromes

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesLacrimal Apparatus Diseases

Study Officials

  • Gaston Lacayo, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 16, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

No data will be shared.

Locations

US(4)