Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime

NCT04212078 | Unknown Phase 1

• 1 other identifier: FF-2019-133
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endophthalmitis Postoperative

Keywords

Intracameral Cefuroxime; Levofloxacin; Corneal Endothelial Cell count; Corneal Morphology

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Side effects

  Post-operative period until study completion, an average of 2 years

Study Arms (2)

A-Levofloxacin

ACTIVE COMPARATOR

0.1 ml/0.5mg of levofloxacin 0.5% ophthalmic solution

Drug: Levofloxacin Ophthalmic

B-Intracameral Cefuroxime

ACTIVE COMPARATOR

0.1 ml/1mg of Cefuroxime

Drug: Cefuroxime

Interventions

Levofloxacin Ophthalmic DRUG

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.

Also known as: Cravit 0.5%

A-Levofloxacin

Cefuroxime DRUG

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.

Also known as: Zinacef

B-Intracameral Cefuroxime

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead
• Santen Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

UKM Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (36)

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MeSH Terms

Interventions

Cefuroxime

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wan Haslina Wan Abdul Halim, M.D

  Department of Ophthalmology, UKM Medical Centre

  STUDY CHAIR

Central Study Contacts

Wan Haslina Wan Abdul Halim, M.D

CONTACT

+6019-6679633; afifiyad@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Ophthalmologist-Cornea And Anterior Segment

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 26, 2019
• Study Start: July 29, 2019
• Primary Completion: January 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)