Dry EyeNCT01016405
Prospective Health Assessment of Cataract Patients' Ocular Surface
An observational study of Dry Eye, run by Innovative Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dry Eye
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- Patients should be at least 55 years old.
- Patients must be scheduled to undergo cataract surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Excellence in Eye Care
Miami, Florida
About this study
Official title: Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)
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
- Dry Eye
- Keywords
- Dry eye, incidence and severity, cataract surgery
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severity of dry eye in patients undergoing cataract surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.
Measured: 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.
Measured: One study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Trattler, MD, Principal investigator, The Center for Excellence in Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016405
- Sponsor's protocol ID
- 0167
- Status last verified
- Jan 2011
- First submitted
- 13 Jul 2009
- Last updated
- 1 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)
- ClinicalTrials.gov ID
- NCT01016405
- Acronym / sponsor ID
- 0167
- Conditions
- Dry Eye
- Keywords
- Dry eye, incidence and severity, cataract surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severity of dry eye in patients undergoing cataract surgery | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (2 listed)
- Patients should be at least 55 years old.
- Patients must be scheduled to undergo cataract surgery.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.
Time frame: One study visit
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Trattler, MD principal investigator
The Center for Excellence in Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye, run by Innovative Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dry eye as evaluated by grade on ITF (International Task Force) level. (time frame: One study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.