Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime

Endophthalmitis Postoperative Clinical Trial

Official title:

Intracameral Levofloxacin (0.5%) Versus Intracameral Cefuroxime (1mg/0.1ml) Effect on Corneal Endothelial Cell Count and Morphology in Uneventful Phacoemulsification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212078
• Other study ID #: FF-2019-133
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 29, 2019
• Est. completion date: October 2022

Study information

• Verified date: September 2020
• Source: National University of Malaysia
• Contact: Wan Haslina Wan Abdul Halim, M.D
• Phone: +6019-6679633
• Email: afifiyad[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: October 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients with senile cataract and age 50 - 80 years

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Endophthalmitis
• Endophthalmitis Postoperative

Intervention

Drug:
• Levofloxacin Ophthalmic
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.
• Cefuroxime
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.

Locations

Country	Name	City	State
Malaysia	UKM Medical Centre	Kuala Lumpur	Wilayah Persekutuan

Sponsors (2)

Lead Sponsor	Collaborator
National University of Malaysia	Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Malaysia, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-week post-operation
Primary	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.	1-month post-operation
Primary	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.	3-month post-operation
Primary	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.	1-week post-operation
Primary	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.	1-month post-operation
Primary	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.	3-month post-operation
Primary	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.	1-week post-operation
Primary	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.	1-month post-operation
Primary	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.	3-month post-operation
Primary	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.	1-week post-operation
Primary	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	1-month post-operation
Primary	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	3-month post-operation
Secondary	Side effects	To report any untoward incidence of endophthalmitis during the study period.	Post-operative period until study completion, an average of 2 years