Endophthalmitis PostoperativePhase 1/2NCT04212078
Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime
A Phase 1/2 study testing Levofloxacin Ophthalmic and Cefuroxime in people with Endophthalmitis Postoperative, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Endophthalmitis Postoperative
- What is being tested?
- Levofloxacin Ophthalmic and Cefuroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 Jul 2019to Oct 2022
- Phase
- Phase 1/2
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with senile cataract and age 50 - 80 years
Who cannot join
- Patients with cataract other than senile cataract (e.g. traumatic cataract)
- Patients with underlying cornea disease (e.g. cornea dystrophy)
- Patients with corneal endothelial disease/endothelial cell count less than 1000/sqmm².
- Patients with intraoperative complications such as posterior capsule rupture/ prolapsed iris/ zonulysis/ anterior vitreous loss.
- Cataract grading nucleosclerosis (NS) 2+ and below.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Kuala Lumpur, Kuala Lumpur, 56000
Wan Haslina Wan Abdul Halim, M.D, +6019-6679633, afifiyad@yahoo.co.uk
Safinaz Mohd Khialdin, M.D.
About this study
Official title: Intracameral Levofloxacin (0.5%) Versus Intracameral Cefuroxime (1mg/0.1ml) Effect on Corneal Endothelial Cell Count and Morphology in Uneventful Phacoemulsification
Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery
Read the detailed description
This is a prospective, double - blinded randomized clinical trial conducted in University Kebangsaan Malaysia Medical Centre (UKMMC). All patients from Ophthalmology Clinic in UKM Medical Centre from December 2018 till June 2021 will be involved in this study. Patients who fulfill the inclusion criteria will be included in this study.
Preoperative assessment includes proper history taking and ocular examinations.Ocular examination includes baseline visual acuity, slit lamp examinations to ascertain the cataract grading, anterior chamber reactions preoperatively, intraocular pressure measurement via applanation tonometry and fundus examinations using 78D condensing lens. Cornea endothelial examinations will be done by using non-contact TOPCON Specular Microscopy model SP-1P.
On the day of surgery, patients will be informed about the two different antibiotics available that will be used at the end of cataract surgery. A written informed consent will be obtained from the patient.
Patients will be randomized before entering the operating theatre. Sealed envelopes total of 4 will be prepared by the researcher; 2 of which will be labelled as A and another 2 envelopes will be labelled as B. The researcher will randomly pick 1 envelope and allocate to patient's file. The staff nurse in charge will then open the envelope, label A or B will then be pasted on the patient's file (rear part) for documentation.
Cataract surgery will be performed byusing Centurion®Vision System, Alcon, Texas, United Stated of America (USA) phacoemulsification machine. 0.3 ml of levofloxacin 0.5% ophthalmic solution (Cravit®, Santen) will be syringed out and at the conclusion of cataract surgery, the solution of 0.1ml which has 0.5 mg levofloxacin will be injected via intracameral into the anterior chamber through the side port wound using a tuberculin syringe in a 27 gauge cannula.
On the other hand, at the beginning part of surgery, cefuroxime will be diluted by the researcher. In order to reduce dilution error and contamination, dilution will be done strictly according to a standardised protocol that was obtained from Malaysian Clinical Practice Guideline. The vial contains 750 mg of cefuroxime powder is diluted with 7.5 ml of Balanced Salt Solution (BSS). 1 ml of the solution will be withdrawn and added with 9 ml of BSS. Then, 0.1 ml of solution which is equivalent to 1 mg of cefuroxime will be aspirated and kept a side. Then the antibiotic of 0.1 ml will be given as intracameral to patient using a tuberculin syringe in a 27 gauge cannula at side port wound at the end of surgery. The side port wound will then be sealed by stromal hydration and checked for water tightness.
This will be followed by instillation of topical guttae ciprofloxacin 0.3% (Ciloxan, Alcon) and guttae dexamethasone 0.1% (Maxidex, Alcon) and eye shield will be applied before leaving the operating theatre.
Patient will be reviewed again after 2 hours post operatively at the slit lamp and eye drops guttae ciprofloxacin 0.3% and guttae dexamethasone 0.1% will be instilled every 2 hours (5 minutes apart from one eye drop to another) for the first one week post-surgery. Upon discharge, patient will be reviewed again in eye clinic after 1 week and during this visit, these eye drops will then be tapered to 4 hourly for two weeks then six hourly for two weeks until next review. After one month the eye drops will be discontinued.
Patients will then be reviewed after one week, one month and three months post operation. During each visit, patient will be examined under slit lamp to look for anterior chamber reaction and to measure intraocular pressure. They will undergo specular microscopy examination to assess cornea endothelial cell count and morphology and central cornea thickness.
- Conditions
- Endophthalmitis Postoperative
- Being tested
- Levofloxacin Ophthalmic, Cefuroxime
- Keywords
- Intracameral Cefuroxime, Levofloxacin, Corneal Endothelial Cell count, Corneal Morphology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin OphthalmicDrug
Also called Cravit 0.5%
0.1ml which has 0.5 mg levofloxacin will be injected via intracameral into the anterior chamber through the side port wound using a tuberculin syringe in a 27 gauge cannula.
CefuroximeDrug
Also called Zinacef
The vial contains 750 mg of cefuroxime powder is diluted with 7.5 ml of Balanced Salt Solution (BSS). 1 ml of the solution will be withdrawn and added with 9 ml of BSS. Then, 0.1 ml of solution which is equivalent to 1 mg of cefuroxime will be aspirated and kept a side. The dissolution of the antibiotic is confirmed by naked eye. Then the antibiotic of 0.1 ml will be given as intracameral to patient using a tuberculin syringe in a 27 gauge cannula at side port wound at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| A-Levofloxacin | Active comparator | 0.1 ml/0.5mg of levofloxacin 0.5% ophthalmic solution Receives: Drug: Levofloxacin Ophthalmic |
| B-Intracameral Cefuroxime | Active comparator | 0.1 ml/1mg of Cefuroxime Receives: Drug: Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-week post-operation
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-month post-operation
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 3-month post-operation
Comparison of change in Endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-week post-operation
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-month post-operation
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 3-month post-operation
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Central cornea thickness (µm) from Baseline, measured at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-week post-operation
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Central cornea thickness (µm) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 1-month post-operation
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Change in Central cornea thickness (µm) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Measured: 3-month post-operation
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 1-week post-operation.
Measured: 1-week post-operation
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 1-month post-operation
Measured: 1-month post-operation
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 3-month post-operation
Measured: 3-month post-operation
Secondary outcomes (1)
Side effects
To report any untoward incidence of endophthalmitis during the study period.
Measured: Post-operative period until study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start29 Jul 2019
- Primary completionJan 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Endophthalmitis PostoperativeStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Santen Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Wan Haslina Wan Abdul Halim, National University of Malaysia
- Investigators
- Wan Haslina Wan Abdul Halim, M.D, Study chair, Department of Ophthalmology, UKM Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212078
- Sponsor's protocol ID
- FF-2019-133
- Status last verified
- Sep 2020
- First submitted
- 10 Dec 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kernt M, Kampik A. Endophthalmitis: Pathogenesis, clinical presentation, management, and perspectives. Clin Ophthalmol. 2010 Mar 24;4:121-35. doi: 10.2147/opth.s6461.
PubMed 20390032Lee MY, Goh PP, Salowi MA, Adnan TH, Ismail M. The Malaysian Cataract Surgery Registry: Cataract Surgery Practice Pattern. Asia Pac J Ophthalmol (Phila). 2014 Nov-Dec;3(6):343-7. doi: 10.1097/APO.0000000000000030.
PubMed 26107976Lockington D, Flowers H, Young D, Yorston D. Assessing the accuracy of intracameral antibiotic preparation for use in cataract surgery. J Cataract Refract Surg. 2010 Feb;36(2):286-9. doi: 10.1016/j.jcrs.2009.08.034.
PubMed 20152612Espiritu CR, Caparas VL, Bolinao JG. Safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution in cataract surgery patients. J Cataract Refract Surg. 2007 Jan;33(1):63-8. doi: 10.1016/j.jcrs.2006.09.019.
PubMed 17189795Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007 Jun;33(6):978-88. doi: 10.1016/j.jcrs.2007.02.032.
PubMed 17531690Montan PG, Wejde G, Setterquist H, Rylander M, Zetterstrom C. Prophylactic intracameral cefuroxime. Evaluation of safety and kinetics in cataract surgery. J Cataract Refract Surg. 2002 Jun;28(6):982-7. doi: 10.1016/s0886-3350(01)01270-6.
PubMed 12036640Friling E, Lundstrom M, Stenevi U, Montan P. Six-year incidence of endophthalmitis after cataract surgery: Swedish national study. J Cataract Refract Surg. 2013 Jan;39(1):15-21. doi: 10.1016/j.jcrs.2012.10.037.
PubMed 23245359Raen M, Sandvik GF, Drolsum L. Endophthalmitis following cataract surgery: the role of prophylactic postoperative chloramphenicol eye drops. Acta Ophthalmol. 2013 Mar;91(2):118-22. doi: 10.1111/j.1755-3768.2011.02324.x. Epub 2011 Dec 13.
PubMed 22151787Shahraki K, Fard MNA, Shahri F, Pourmatin R, Mohammadi T, Boroumand PG, Shahraki K. Effects of intracameral cefuroxime on corneal endothelial cell counts and its morphology after cataract surgery. Interv Med Appl Sci. 2017 Jun;9(2):100-104. doi: 10.1556/1646.9.2017.2.13.
PubMed 28932504Cakir B, Celik E, Aksoy NO, Bursali O, Ucak T, Bozkurt E, Alagoz G. Toxic anterior segment syndrome after uncomplicated cataract surgery possibly associated with intracamaral use of cefuroxime. Clin Ophthalmol. 2015 Mar 17;9:493-7. doi: 10.2147/OPTH.S74249. eCollection 2015.
PubMed 25834384Louis B.Cantor, Christopher J. Rapuano, George A. Cioffi. Basic and Clinical Science Course. Section 9: Intraocular inflammation and uveitis. American Academy of Ophthalmology 2014-2015;8;261.
Management of Post-operative Infectious Endophthalmitis. Clinical Practice Guideline. August 2006. Ministry of Health Malaysia.
Matsuura K, Miyoshi T, Suto C, Akura J, Inoue Y. Efficacy and safety of prophylactic intracameral moxifloxacin injection in Japan. J Cataract Refract Surg. 2013 Nov;39(11):1702-6. doi: 10.1016/j.jcrs.2013.05.036. Epub 2013 Sep 18.
PubMed 24054967Mather R, Karenchak LM, Romanowski EG, Kowalski RP. Fourth generation fluoroquinolones: new weapons in the arsenal of ophthalmic antibiotics. Am J Ophthalmol. 2002 Apr;133(4):463-6. doi: 10.1016/s0002-9394(02)01334-x.
PubMed 11931779Kim SY, Park YH, Lee YC. Comparison of the effect of intracameral moxifloxacin, levofloxacin and cefazolin on rabbit corneal endothelial cells. Clin Exp Ophthalmol. 2008 May;36(4):367-70. doi: 10.1111/j.1442-9071.2008.01771.x.
PubMed 18700925
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracameral Levofloxacin (0.5%) Versus Intracameral Cefuroxime (1mg/0.1ml) Effect on Corneal Endothelial Cell Count and Morphology in Uneventful Phacoemulsification
- ClinicalTrials.gov ID
- NCT04212078
- Acronym / sponsor ID
- FF-2019-133
- Conditions
- Endophthalmitis Postoperative
- Keywords
- Intracameral Cefuroxime, Levofloxacin, Corneal Endothelial Cell count, Corneal Morphology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Santen Pharmaceutical Co., Ltd.
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 26 Dec 2019 (actual)
- 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.
Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery
Detailed description
This is a prospective, double - blinded randomized clinical trial conducted in University Kebangsaan Malaysia Medical Centre (UKMMC). All patients from Ophthalmology Clinic in UKM Medical Centre from December 2018 till June 2021 will be involved in this study. Patients who fulfill the inclusion criteria will be included in this study.
Preoperative assessment includes proper history taking and ocular examinations.Ocular examination includes baseline visual acuity, slit lamp examinations to ascertain the cataract grading, anterior chamber reactions preoperatively, intraocular pressure measurement via applanation tonometry and fundus examinations using 78D condensing lens. Cornea endothelial examinations will be done by using non-contact TOPCON Specular Microscopy model SP-1P.
On the day of surgery, patients will be informed about the two different antibiotics available that will be used at the end of cataract surgery. A written informed consent will be obtained from the patient.
Patients will be randomized before entering the operating theatre. Sealed envelopes total of 4 will be prepared by the researcher; 2 of which will be labelled as A and another 2 envelopes will be labelled as B. The researcher will randomly pick 1 envelope and allocate to patient's file. The staff nurse in charge will then open the envelope, label A or B will then be pasted on the patient's file (rear part) for documentation.
Cataract surgery will be performed byusing Centurion®Vision System, Alcon, Texas, United Stated of America (USA) phacoemulsification machine. 0.3 ml of levofloxacin 0.5% ophthalmic solution (Cravit®, Santen) will be syringed out and at the conclusion of cataract surgery, the solution of 0.1ml which has 0.5 mg levofloxacin will be injected via intracameral into the anterior chamber through the side port wound using a tuberculin syringe in a 27 gauge cannula.
On the other hand, at the beginning part of surgery, cefuroxime will be diluted by the researcher. In order to reduce dilution error and contamination, dilution will be done strictly according to a standardised protocol that was obtained from Malaysian Clinical Practice Guideline. The vial contains 750 mg of cefuroxime powder is diluted with 7.5 ml of Balanced Salt Solution (BSS). 1 ml of the solution will be withdrawn and added with 9 ml of BSS. Then, 0.1 ml of solution which is equivalent to 1 mg of cefuroxime will be aspirated and kept a side. Then the antibiotic of 0.1 ml will be given as intracameral to patient using a tuberculin syringe in a 27 gauge cannula at side port wound at the end of surgery. The side port wound will then be sealed by stromal hydration and checked for water tightness.
This will be followed by instillation of topical guttae ciprofloxacin 0.3% (Ciloxan, Alcon) and guttae dexamethasone 0.1% (Maxidex, Alcon) and eye shield will be applied before leaving the operating theatre.
Patient will be reviewed again after 2 hours post operatively at the slit lamp and eye drops guttae ciprofloxacin 0.3% and guttae dexamethasone 0.1% will be instilled every 2 hours (5 minutes apart from one eye drop to another) for the first one week post-surgery. Upon discharge, patient will be reviewed again in eye clinic after 1 week and during this visit, these eye drops will then be tapered to 4 hourly for two weeks then six hourly for two weeks until next review. After one month the eye drops will be discontinued.
Patients will then be reviewed after one week, one month and three months post operation. During each visit, patient will be examined under slit lamp to look for anterior chamber reaction and to measure intraocular pressure. They will undergo specular microscopy examination to assess cornea endothelial cell count and morphology and central cornea thickness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-Levofloxacin | Active comparator | Drug: Levofloxacin Ophthalmic0.1 ml/0.5mg of levofloxacin 0.5% ophthalmic solution |
| B-Intracameral Cefuroxime | Active comparator | Drug: Cefuroxime0.1 ml/1mg of Cefuroxime |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with senile cataract and age 50 - 80 years
Key exclusion criteria (5 listed)
- Patients with cataract other than senile cataract (e.g. traumatic cataract)
- Patients with underlying cornea disease (e.g. cornea dystrophy)
- Patients with corneal endothelial disease/endothelial cell count less than 1000/sqmm².
- Patients with intraoperative complications such as posterior capsule rupture/ prolapsed iris/ zonulysis/ anterior vitreous loss.
- Cataract grading nucleosclerosis (NS) 2+ and below.
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 |
|---|---|---|
| Levofloxacin OphthalmicAlso: Cravit 0.5%0.1ml which has 0.5 mg levofloxacin will be injected via intracameral into the anterior chamber through the side port wound using a tuberculin syringe in a 27 gauge cannula. | Drug | A-Levofloxacin |
| CefuroximeAlso: ZinacefThe vial contains 750 mg of cefuroxime powder is diluted with 7.5 ml of Balanced Salt Solution (BSS). 1 ml of the solution will be withdrawn and added with 9 ml of BSS. Then, 0.1 ml of solution which is equivalent to 1 mg of cefuroxime will be aspirated and kept a side. The dissolution of the antibiotic is confirmed by naked eye. Then the antibiotic of 0.1 ml will be given as intracameral to patient using a tuberculin syringe in a 27 gauge cannula at side port wound at the end of surgery. | Drug | B-Intracameral Cefuroxime |
Primary outcome
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-week post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-month post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 3-month post-operation
Change in Concentration of Endothelial cell count (cells/mm2) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-week post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-month post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in endothelial cell morphology in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 3-month post-operation
Change in Endothelial cell morphology from Baseline by assessing the Polymegathism (CV) which is the variation in individual cell areas, and Pleomorphism which is the increased in variability of cell shape, at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-week post-operation
Change in Central cornea thickness (µm) from Baseline, measured at 1-week post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-month post-operation
Change in Central cornea thickness (µm) from Baseline, measured at 1-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of change in Central cornea thickness in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 3-month post-operation
Change in Central cornea thickness (µm) from Baseline, measured at 3-month post-operation using a non-contact TOPCON Specular Microscopy model SP-1P.
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-week post-operation
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 1-week post-operation.
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 1-month post-operation
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 1-month post-operation
Comparison of Anterior chamber reaction in patients treated with intracameral levofloxacin ophthalmic solution with intracameral cefuroxime in an uneventful phacoemulsification.
Time frame: 3-month post-operation
Anterior chamber cell grading refers to presence of inflammatory reaction in the anterior chamber (the space in front of iris plane and cornea endothelium). It is graded by counting the number of cells that is present with slit beam of 1mm x 1mm with high intensity of light measured using the slit lamp at 3-month post-operation
1 secondary outcome
Side effects
Time frame: Post-operative period until study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 20390032Kernt M, Kampik A. Endophthalmitis: Pathogenesis, clinical presentation, management, and perspectives. Clin Ophthalmol. 2010 Mar 24;4:121-35. doi: 10.2147/opth.s6461.
- Background: PubMed 26107976Lee MY, Goh PP, Salowi MA, Adnan TH, Ismail M. The Malaysian Cataract Surgery Registry: Cataract Surgery Practice Pattern. Asia Pac J Ophthalmol (Phila). 2014 Nov-Dec;3(6):343-7. doi: 10.1097/APO.0000000000000030.
- Background: PubMed 20152612Lockington D, Flowers H, Young D, Yorston D. Assessing the accuracy of intracameral antibiotic preparation for use in cataract surgery. J Cataract Refract Surg. 2010 Feb;36(2):286-9. doi: 10.1016/j.jcrs.2009.08.034.
- Background: PubMed 17189795Espiritu CR, Caparas VL, Bolinao JG. Safety of prophylactic intracameral moxifloxacin 0.5% ophthalmic solution in cataract surgery patients. J Cataract Refract Surg. 2007 Jan;33(1):63-8. doi: 10.1016/j.jcrs.2006.09.019.
- Background: PubMed 17531690Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007 Jun;33(6):978-88. doi: 10.1016/j.jcrs.2007.02.032.
- Background: PubMed 12036640Montan PG, Wejde G, Setterquist H, Rylander M, Zetterstrom C. Prophylactic intracameral cefuroxime. Evaluation of safety and kinetics in cataract surgery. J Cataract Refract Surg. 2002 Jun;28(6):982-7. doi: 10.1016/s0886-3350(01)01270-6.
- Background: PubMed 23245359Friling E, Lundstrom M, Stenevi U, Montan P. Six-year incidence of endophthalmitis after cataract surgery: Swedish national study. J Cataract Refract Surg. 2013 Jan;39(1):15-21. doi: 10.1016/j.jcrs.2012.10.037.
- Background: PubMed 22151787Raen M, Sandvik GF, Drolsum L. Endophthalmitis following cataract surgery: the role of prophylactic postoperative chloramphenicol eye drops. Acta Ophthalmol. 2013 Mar;91(2):118-22. doi: 10.1111/j.1755-3768.2011.02324.x. Epub 2011 Dec 13.
- Background: PubMed 28932504Shahraki K, Fard MNA, Shahri F, Pourmatin R, Mohammadi T, Boroumand PG, Shahraki K. Effects of intracameral cefuroxime on corneal endothelial cell counts and its morphology after cataract surgery. Interv Med Appl Sci. 2017 Jun;9(2):100-104. doi: 10.1556/1646.9.2017.2.13.
- Background: PubMed 25834384Cakir B, Celik E, Aksoy NO, Bursali O, Ucak T, Bozkurt E, Alagoz G. Toxic anterior segment syndrome after uncomplicated cataract surgery possibly associated with intracamaral use of cefuroxime. Clin Ophthalmol. 2015 Mar 17;9:493-7. doi: 10.2147/OPTH.S74249. eCollection 2015.
- BackgroundLouis B.Cantor, Christopher J. Rapuano, George A. Cioffi. Basic and Clinical Science Course. Section 9: Intraocular inflammation and uveitis. American Academy of Ophthalmology 2014-2015;8;261.
- BackgroundManagement of Post-operative Infectious Endophthalmitis. Clinical Practice Guideline. August 2006. Ministry of Health Malaysia.
- Individual participant dataSharing planned: No
Related trials for Endophthalmitis Postoperative
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingObservational study
Vascular Changes Associated With Endophthalmitis.
Endophthalmitis
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.
Wan Haslina Wan Abdul Halim, M.D study chair
Department of Ophthalmology, UKM Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Levofloxacin Ophthalmic and Cefuroxime in people with Endophthalmitis Postoperative, run by National University of Malaysia at 1 site in Malaysia.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2020. 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 Malaysia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Haslina Wan Abdul Halim, M.D (+6019-6679633, afifiyad@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in Endothelial cell count concentration in patients treated with intracameral levofloxacin ophthalmic solution and intracameral cefuroxime in an uneventful phacoemulsification. (time frame: 1-week post-operation). The study lists 12 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 NCT04212078, which also lists 36 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 21 Sep 2020.