EndophthalmitisNCT00335231
Preoperative Topical Gatifloxacin on Anterior Chamber Cultures After Cataract Surgery
A study testing gatifloxacin ophthalmic (ZYMAR) in people with Endophthalmitis, run by Queen's University at 1 site in Canada.
Trial summary
Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- gatifloxacin ophthalmic (ZYMAR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Jun 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cataract surgery on first eye (i.e., first cataract surgery.
Who cannot join
- uveitis,
- herpetic eye disease,
- corneal ulceration,
- severe blepharitis,
- past trauma to the eye,
- complicated cataract surgery (e.g., posterior capsule rupture),
- previous intraocular surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.
Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. However, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. This study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. If the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis.
Patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. The participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e., colony forming units (CFUs), will be used as an indicator of the bacterial contamination of the fluid.
- Conditions
- Endophthalmitis
- Being tested
- gatifloxacin ophthalmic (ZYMAR)
- Keywords
- Post-cataract surgery endophthalmitis
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gatifloxacin ophthalmic (ZYMAR)Drug
| Study group | Role | What they receive |
|---|---|---|
| gatifloxacin | Experimental | one group will receive topical application of gatifloxacin prior to surgery, Receives: Drug: gatifloxacin ophthalmic (ZYMAR) |
| no eye drops | No intervention | this group will receive no eye drops. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
Secondary outcomes (2)
Bacterial sensitivity
Patient comfort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Protocol changes underway. Trial never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherif El-Defrawy, MD PhD FRCSC, Principal investigator, Queen's University, Hotel Dieu Hospital, Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335231
- Sponsor's protocol ID
- QUEENS-SRE-3
- Status last verified
- Apr 2018
- First submitted
- 8 Jun 2006
- Last updated
- 2 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Topical Gatifloxacin on Anterior Chamber Sample Cultures After Cataract Surgery.
- ClinicalTrials.gov ID
- NCT00335231
- Acronym / sponsor ID
- QUEENS-SRE-3
- Conditions
- Endophthalmitis
- Keywords
- Post-cataract surgery endophthalmitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol changes underway. Trial never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Jun 2006 (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.
Postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. Bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. However, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. Also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. This study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. If the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis.
Patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. The participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. During surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. Bacterial growth, i.e., colony forming units (CFUs), will be used as an indicator of the bacterial contamination of the fluid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gatifloxacin | Experimental | Drug: gatifloxacin ophthalmic (ZYMAR)one group will receive topical application of gatifloxacin prior to surgery, |
| no eye drops | No intervention | –this group will receive no eye drops. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cataract surgery on first eye (i.e., first cataract surgery.
Key exclusion criteria (7 listed)
- uveitis,
- herpetic eye disease,
- corneal ulceration,
- severe blepharitis,
- past trauma to the eye,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gatifloxacin ophthalmic (ZYMAR) | Drug | gatifloxacin |
Primary outcome
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group
2 secondary outcomes
Bacterial sensitivity
Patient comfort
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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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.
Sherif El-Defrawy, MD PhD FRCSC principal investigator
Queen's University, Hotel Dieu Hospital, Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gatifloxacin ophthalmic (ZYMAR) in people with Endophthalmitis, run by Queen's University at 1 site in Canada.
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 1 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 May 2018. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Difference in bacterial colony forming units (CFUs) between treatment (gatifloxacin) and no treatment group. 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 2 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.