Conjunctival Bacterial FloraPhase 4NCT00491049
Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery
A Phase 4 study testing 0.5% levofloxacin eye drops in people with Conjunctival Bacterial Flora, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether additional topical application of 0.5% levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva with povidone iodine alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctival Bacterial Flora
- What is being tested?
- 0.5% levofloxacin eye drops
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Apr 2005
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery for cataract, glaucoma or vitrectomy
Who cannot join
- Patients who report to be allergic to levofloxacin or iodine
- Patients on topical antibiotic within the last 30 days
- Patients with acute conjunctivitis, blepharitis or dacryocystitis
- Patients under age of 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study on Effectiveness of Topical 0.5% Levofloxacin on Reduction of Preoperative Conjunctival Flora in Patients Scheduled for Intraocular Surgery
The purpose of this study is to determine whether additional topical application of 0.5% levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva with povidone iodine alone.
Read the detailed description
Endophthalmitis is serious complication of intraocular surgery. Previous studies have shown that the most common sources of bacteria causing endophthalmitis are the patients eyelid and conjunctival bacteria. [1, 2] The risk of postoperative endophthalmitis may be reduced by eliminating bacteria from the ocular surface at the time of the surgery.
The current standard for endophthalmitis prophylaxis at Ludwig-Maximilians-University in Munich, Germany is the irrigation of the conjunctival fornices with 1% povidone-iodine (PVI) prior to surgery. In general, patients do not receive topical antibiotic prior to surgery.
Ta and co-workers have demonstrated that a three-day application of topical ofloxacin resulted in less conjunctival cultures obtained before and after surgery compared to an application of antibiotic given one hour prior to surgery.[3] Furthermore, the same research group showed that the contamination rate of the microsurgical knives used during surgery decreased from 26% to 5% (P = 0.028) with a three day application of ofloxacin compared to a one-hour application.[4] The goal of the current proposal is to determine if we can improve on the current standard of endophthalmitis prophylaxis at Ludwig-Maximilians-University by using topical 5% levofloxacin prior to surgery. Given that the rate of endophthalmitis is quite low, we will use conjunctival bacterial flora and anterior chamber aqueous contamination rate as surrogate markers to determine the effectiveness of topical levofloxacin in reducing or eliminating bacteria from the ocular surface at the time of the surgery. The results of this prospective-randomized control trial may radically change the current practice of endophthalmitis prophylaxis, and levofloxacin may play a critical role in preventing postoperative endophthalmitis.
Study Protocol:
One hundred and forty patients will be randomized to control group and a study group:
- Control group: no antibiotic (70 patients). Standard protocol at the Department of Ophthalmology, Munich.
- Study group I: topical 0.5% levofloxacin four times per day for one day prior to surgery. In addition, one drop of topical levofloxacin is given three times with five minutes intervals, one hour prior to surgery (70 patients).
Five minutes prior to surgery both groups will receive topical povidone-iodine (10%) to scrub the periorbital area and 1% PVI to irrigate the conjunctiva (standard protocol). Patients will be draped in a sterile fashion and surgery will be initiated.
Conjunctival cultures for aerobic and anaerobic bacteria will be obtained at the following time-points:
- T0: (Baseline) at the day of the first interview (one week before surgery), prior to any application of antibiotic or povidone-iodine. Samples will be taken from both conjunctivas.
- T1: On the morning of the surgery, but prior to final treatment during the last hour before surgery. At this time, patients in both study groups will have received topical levofloxacin (one day and three days before surgery) treatment; patients in the control group will not have received any treatment with antibiotic. Samples will be taken also from both conjunctiva.
- T2: Immediately before surgery, 5-10 min after PVI scrub and PVI irrigation for both the control and study group, but only on the conjunctiva of surgery eye. In addition of sample of anterior chamber aqueous fluid is taken from the surgery eye by the responsible surgeon.
- T3: At the conclusion of surgery, again from the conjunctiva and the anterior chamber fluid of the surgery eye.
At every step, samples are taken from the conjunctiva with a standard dissolving Ca-alginate swab (Sanofi-Pasteur, Germany). The moistened swab should be taken via one rotational swipe over the lower conjunctiva without touching the lid or eyelashes. Additionally anterior chamber aqueous fluid will be obtained immediately before and after surgery. The cannulas (2x) used for the aspiration will be cultured in a separate broth culture, too.
Inclusion criteria:
- Patients undergoing surgery for cataract, glaucoma or vitrectomy.
Exclusion criteria:
- Patients who report to be allergic to levofloxacin or iodine
- Patients on topical antibiotic within the last 30 days
- Patients with acute conjunctivitis, blepharitis or dacryocystitis
- Patients under age of 18 years
Summary:
The results of this study may revolutionize the standard of endophthalmitis prophylaxis. It could be that the application of topical levofloxacin 5%, four times a day for one or three days prior to surgery, significantly reduce or eliminate bacteria from the ocular surface. Hence, topical levofloxacin may have a critical role in preventing postoperative endophthalmitis.
- Conditions
- Conjunctival Bacterial Flora
- Being tested
- 0.5% levofloxacin eye drops
- Keywords
- prophylaxis, intraocular surgery, endophthalmitis, antibiotic
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% levofloxacin eye dropsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points
Measured: maximum 7 days before surgery until conclusion of surgery
Secondary outcomes (1)
Numbers of colony forming units (CFUs) found on solid media. Specimens were cultured aerobically and micro-aerobically on blood agar plates and anaerobically on chocolate agar plates and CFUs were determined on each plate using a magnifying glass.
Measured: maximum 7 days before surgery until concluison of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startSep 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Conjunctival Bacterial FloraStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Gmbh
- Investigators
- Herminia Mino de Kapsar, PhD, Principal investigator, Augenklinik der LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491049
- Sponsor's protocol ID
- LevoProMUC03
- Status last verified
- Jun 2007
- First submitted
- 21 Jun 2007
- Last updated
- 25 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5.
PubMed 2062496Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.
PubMed 9076208Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. doi: 10.1016/s0161-6420(02)01236-8.
PubMed 12414411De Kaspar HM, Chang RT, Shriver EM, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Three-day application of topical ofloxacin reduces the contamination rate of microsurgical knives in cataract surgery: a prospective randomized study. Ophthalmology. 2004 Jul;111(7):1352-5. doi: 10.1016/j.ophtha.2003.10.032.
PubMed 15234136Mino de Kaspar H, Chang RT, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Prospective randomized comparison of 2 different methods of 5% povidone-iodine applications for anterior segment intraocular surgery. Arch Ophthalmol. 2005 Feb;123(2):161-5. doi: 10.1001/archopht.123.2.161.
PubMed 15710810Mino de Kaspar H, Kreutzer TC, Aguirre-Romo I, Ta CN, Dudichum J, Bayrhof M, Klauss V, Kampik A. A prospective randomized study to determine the efficacy of preoperative topical levofloxacin in reducing conjunctival bacterial flora. Am J Ophthalmol. 2008 Jan;145(1):136-142. doi: 10.1016/j.ajo.2007.08.031. Epub 2007 Nov 8.
PubMed 17996212
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study on Effectiveness of Topical 0.5% Levofloxacin on Reduction of Preoperative Conjunctival Flora in Patients Scheduled for Intraocular Surgery
- ClinicalTrials.gov ID
- NCT00491049
- Acronym / sponsor ID
- LevoProMUC03
- Conditions
- Conjunctival Bacterial Flora
- Keywords
- prophylaxis, intraocular surgery, endophthalmitis, antibiotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Santen Gmbh
- Study start
- Sep 2004
- Study completion
- Apr 2005 (actual)
- First posted
- 25 Jun 2007 (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.
The purpose of this study is to determine whether additional topical application of 0.5% levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva with povidone iodine alone.
Detailed description
Endophthalmitis is serious complication of intraocular surgery. Previous studies have shown that the most common sources of bacteria causing endophthalmitis are the patients eyelid and conjunctival bacteria. [1, 2] The risk of postoperative endophthalmitis may be reduced by eliminating bacteria from the ocular surface at the time of the surgery.
The current standard for endophthalmitis prophylaxis at Ludwig-Maximilians-University in Munich, Germany is the irrigation of the conjunctival fornices with 1% povidone-iodine (PVI) prior to surgery. In general, patients do not receive topical antibiotic prior to surgery.
Ta and co-workers have demonstrated that a three-day application of topical ofloxacin resulted in less conjunctival cultures obtained before and after surgery compared to an application of antibiotic given one hour prior to surgery.[3] Furthermore, the same research group showed that the contamination rate of the microsurgical knives used during surgery decreased from 26% to 5% (P = 0.028) with a three day application of ofloxacin compared to a one-hour application.[4] The goal of the current proposal is to determine if we can improve on the current standard of endophthalmitis prophylaxis at Ludwig-Maximilians-University by using topical 5% levofloxacin prior to surgery. Given that the rate of endophthalmitis is quite low, we will use conjunctival bacterial flora and anterior chamber aqueous contamination rate as surrogate markers to determine the effectiveness of topical levofloxacin in reducing or eliminating bacteria from the ocular surface at the time of the surgery. The results of this prospective-randomized control trial may radically change the current practice of endophthalmitis prophylaxis, and levofloxacin may play a critical role in preventing postoperative endophthalmitis.
Study Protocol:
One hundred and forty patients will be randomized to control group and a study group:
- Control group: no antibiotic (70 patients). Standard protocol at the Department of Ophthalmology, Munich.
- Study group I: topical 0.5% levofloxacin four times per day for one day prior to surgery. In addition, one drop of topical levofloxacin is given three times with five minutes intervals, one hour prior to surgery (70 patients).
Five minutes prior to surgery both groups will receive topical povidone-iodine (10%) to scrub the periorbital area and 1% PVI to irrigate the conjunctiva (standard protocol). Patients will be draped in a sterile fashion and surgery will be initiated.
Conjunctival cultures for aerobic and anaerobic bacteria will be obtained at the following time-points:
- T0: (Baseline) at the day of the first interview (one week before surgery), prior to any application of antibiotic or povidone-iodine. Samples will be taken from both conjunctivas.
- T1: On the morning of the surgery, but prior to final treatment during the last hour before surgery. At this time, patients in both study groups will have received topical levofloxacin (one day and three days before surgery) treatment; patients in the control group will not have received any treatment with antibiotic. Samples will be taken also from both conjunctiva.
- T2: Immediately before surgery, 5-10 min after PVI scrub and PVI irrigation for both the control and study group, but only on the conjunctiva of surgery eye. In addition of sample of anterior chamber aqueous fluid is taken from the surgery eye by the responsible surgeon.
- T3: At the conclusion of surgery, again from the conjunctiva and the anterior chamber fluid of the surgery eye.
At every step, samples are taken from the conjunctiva with a standard dissolving Ca-alginate swab (Sanofi-Pasteur, Germany). The moistened swab should be taken via one rotational swipe over the lower conjunctiva without touching the lid or eyelashes. Additionally anterior chamber aqueous fluid will be obtained immediately before and after surgery. The cannulas (2x) used for the aspiration will be cultured in a separate broth culture, too.
Inclusion criteria:
- Patients undergoing surgery for cataract, glaucoma or vitrectomy.
Exclusion criteria:
- Patients who report to be allergic to levofloxacin or iodine
- Patients on topical antibiotic within the last 30 days
- Patients with acute conjunctivitis, blepharitis or dacryocystitis
- Patients under age of 18 years
Summary:
The results of this study may revolutionize the standard of endophthalmitis prophylaxis. It could be that the application of topical levofloxacin 5%, four times a day for one or three days prior to surgery, significantly reduce or eliminate bacteria from the ocular surface. Hence, topical levofloxacin may have a critical role in preventing postoperative endophthalmitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgery for cataract, glaucoma or vitrectomy
Key exclusion criteria (4 listed)
- Patients who report to be allergic to levofloxacin or iodine
- Patients on topical antibiotic within the last 30 days
- Patients with acute conjunctivitis, blepharitis or dacryocystitis
- Patients under age of 18 years
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 |
|---|---|---|
| 0.5% levofloxacin eye drops | Drug | – |
Primary outcome
Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points
Time frame: maximum 7 days before surgery until conclusion of surgery
1 secondary outcome
Numbers of colony forming units (CFUs) found on solid media. Specimens were cultured aerobically and micro-aerobically on blood agar plates and anaerobically on chocolate agar plates and CFUs were determined on each plate using a magnifying glass.
Time frame: maximum 7 days before surgery until concluison of surgery
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 25 Jun 2007.
- Background: PubMed 2062496Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650. doi: 10.1016/s0161-6420(91)32239-5.
- Background: PubMed 9076208Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.
- Background: PubMed 12414411Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1. doi: 10.1016/s0161-6420(02)01236-8.
- Background: PubMed 15234136De Kaspar HM, Chang RT, Shriver EM, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Three-day application of topical ofloxacin reduces the contamination rate of microsurgical knives in cataract surgery: a prospective randomized study. Ophthalmology. 2004 Jul;111(7):1352-5. doi: 10.1016/j.ophtha.2003.10.032.
- Background: PubMed 15710810Mino de Kaspar H, Chang RT, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Prospective randomized comparison of 2 different methods of 5% povidone-iodine applications for anterior segment intraocular surgery. Arch Ophthalmol. 2005 Feb;123(2):161-5. doi: 10.1001/archopht.123.2.161.
- Derived from this study: PubMed 17996212Mino de Kaspar H, Kreutzer TC, Aguirre-Romo I, Ta CN, Dudichum J, Bayrhof M, Klauss V, Kampik A. A prospective randomized study to determine the efficacy of preoperative topical levofloxacin in reducing conjunctival bacterial flora. Am J Ophthalmol. 2008 Jan;145(1):136-142. doi: 10.1016/j.ajo.2007.08.031. Epub 2007 Nov 8.
- Website of the university eye hospital at the Ludwig-Maximilians University in MunichLink provided by the sponsor.
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.
Herminia Mino de Kapsar, PhD principal investigator
Augenklinik der LMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5% levofloxacin eye drops in people with Conjunctival Bacterial Flora, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 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 25 Jun 2007. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points (time frame: maximum 7 days before surgery until conclusion of surgery). 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 NCT00491049, which also lists 6 linked publications.
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 25 Jun 2007.