CataractNCT00621933

Surveillance of Ocular Surface Flora (SURFACE)

An observational study of Cataract, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Cataract
How many people: 399 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Nov 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Cataract Surgery Patients

Who may be able to join

Scheduled to undergo cataract surgery
Able to provide written informed consent

Who cannot join

NSAID in the eye to be swabbed within the past 30 days
Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days
Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial
History of conjunctivitis or any ocular infection within the past 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Salt Lake City, Utah

Other trials in United States

About this study

Conditions: Cataract
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00621933
Study group	Role	What they receive
All Patients Receiving Cataract Surgery		All Patients Receiving Cataract Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).
Measured: Baseline
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).
Measured: Baseline

Secondary outcomes (2)

Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid
Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).
Measured: Baseline
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were <= 2 ug/ml (susceptible) and >= 4 ug/ml (resistant).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Nov 2008

First posted22 Feb 2008 (estimated)
Study startDec 2007
Primary completionOct 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CataractStudies 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: Cohort
Time perspective: Prospective
Enrolment: 399 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621933
Sponsor's protocol ID: MA-Zymar-08-001
Status last verified: Apr 2019
First submitted: 13 Feb 2008
Last updated: 26 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Olson R, Donnenfeld E, Bucci FA Jr, Price FW Jr, Raizman M, Solomon K, Devgan U, Trattler W, Dell S, Wallace RB, Callegan M, Brown H, McDonnell PJ, Conway T, Schiffman RM, Hollander DA. Methicillin resistance of Staphylococcus species among health care and nonhealth care workers undergoing cataract surgery. Clin Ophthalmol. 2010 Dec 10;4:1505-14. doi: 10.2147/OPTH.S14333.
PubMed 21191448

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surveillance of Ocular Surface Flora (SURFACE)
ClinicalTrials.gov ID: NCT00621933
Acronym / sponsor ID: MA-Zymar-08-001
Conditions: Cataract
Study type: Observational
Recruitment status: Completed
Enrolment: 399 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Oct 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 18 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Patients Receiving Cataract Surgery	–	–All Patients Receiving Cataract Surgery

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Cataract Surgery Patients

Key inclusion criteria (2 listed)

Scheduled to undergo cataract surgery
Able to provide written informed consent

Key exclusion criteria (4 listed)

NSAID in the eye to be swabbed within the past 30 days
Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days
Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial
History of conjunctivitis or any ocular infection within the past 3 months

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

Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid
Time frame: Baseline
Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Time frame: Baseline
Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were <= 0.25 ug/ml (susceptible) and >= 0.50 ug/ml (resistant).

2 secondary outcomes

Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid
Time frame: Baseline
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva
Time frame: Baseline

Results and safety

Results posted to the registry on 18 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	399	399

Primary outcome: Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid

Time frame: Baseline. Number. Unit: Percentage of Species

Measure	All Patients n = 399
Percentage of Species Oxacillin-Susceptible	51
Percentage of Species Oxacillin-Resistant	48

Population analysed: ITT population. All patients with cultures performed of the ocular surface.

Primary outcome: Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva

Time frame: Baseline. Number. Unit: Percentage of Species

Measure	All Patients n = 399
Percentage of Species Oxacillin-Susceptible	52
Percentage of Species Oxacillin-Resistant	45

Population analysed: ITT population. All patients with cultures performed of the ocular surface.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21191448Olson R, Donnenfeld E, Bucci FA Jr, Price FW Jr, Raizman M, Solomon K, Devgan U, Trattler W, Dell S, Wallace RB, Callegan M, Brown H, McDonnell PJ, Conway T, Schiffman RM, Hollander DA. Methicillin resistance of Staphylococcus species among health care and nonhealth care workers undergoing cataract surgery. Clin Ophthalmol. 2010 Dec 10;4:1505-14. doi: 10.2147/OPTH.S14333.

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RecruitingObservational study
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Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
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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.

Medical Director study director

Allergan

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 Cataract, run by Allergan 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 4 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 26 Apr 2019. 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?

Yes. Results are posted in the registry (first posted 18 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00621933, which also lists 1 linked publication.

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 26 Apr 2019.