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Prospective Health Assessment of Cataract Patients' Ocular Surface

Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01016405
Enrollment
200
Registered
2009-11-19
Start date
2009-06-30
Completion date
2010-09-30
Last updated
2011-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Dry eye, incidence and severity, cataract surgery

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.

Interventions

None listed

Sponsors

Innovative Medical
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026