CompletedNCT01016405Updated Feb 1, 2011

Prospective Health Assessment of Cataract Patients' Ocular Surface

An observational study in Dry Eye, sponsored by Innovative Medical. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2011-02-01.

Sponsored by Innovative Medical · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 200
Ages: 55 Years and older
Sex: All

Study 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.

Conditions studied

Dry Eye

Browse trials for

Keywords

Dry eye
incidence and severity
cataract surgery

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 200 is above the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Innovative Medical is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 55 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Primary care clinic.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 200 participants (estimated)

Groups and cohorts

Severity of dry eye in patients undergoing cataract surgery

What researchers measure

Primary outcomes

Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.
Time frame: One study visit

Secondary outcomes

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.
Time frame: One study visit

Study locations

1 site

The Center for Excellence in Eye Care
Miami, Florida, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01016405
Lead sponsor: Innovative Medical
First posted: Nov 19, 2009
Start date: Jun 2009
Primary completion: Sep 2010
Completion: Sep 2010
Last update: Feb 1, 2011

Study contacts

William Trattler, MD

principal investigator · The Center for Excellence in Eye Care

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cataract→

Other studies from this sponsor

Innovative Medical

Start the discussion