Cataract
Conditions
Keywords
Moxifloxacin, Levofloxacin, Cataract surgery
Brief summary
The goal of this randomized clinical trial study is to compare safety profile undiluted intracameral moxifloxacin vs levofloxacin during cataract surgery. The main question it aims to answer is whether moxifloxacin and levofloxacin have similar safety profile. Participant will be randomized into two treatment arms. All participant will receive standardized treatment before, during, and after surgery and will be followed up at one day, one week, and one month after surgery.
Detailed description
This study aims to observe the safety profile in patient receiving cataract surgery who receives moxifloxacin and levofloxacin intracamerally during the surgery. Safety profile defined as visual acuity, intraocular pressure, corneal endothelial cell density, central corneal thickness, anterior chamber reactions, and central macular thickness. Parameters are obtained before the surgery, 1 day, 1 week, and 1 month after surgery. Subjects are randomized to two treatment arms: (1) receiving undiluted moxifloxacin 0.1 cc during surgery; (2) receiving undiluted levofloxacin 0.1 cc during surgery.
Interventions
Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery
Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery
Sponsors
Ferron Par Pharmaceuticals
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant will be masked receiving treatment, post operative eye drops of both arms is the same. Subject allocation is blinded to investigator and outcomes assessor.
Intervention model description
First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Immature senile cataract in one or both eye * Agree to be included and signed informed consent
Exclusion criteria
* Have a history of allergy to moxifloxacin or levofloxacin or any other antibiotics * Other ocular comorbid such as uveitis, glaucoma, diabetic retinopathy, pseudoexfoliation, and endothelial disorders * Ocular surgery prior to study * Sign of infection or inflammation around the eye * Cataract density more than grade 4 according to Lens Opacities Classification System (LOCS) III grading * Corneal endothelial cell density \< 1500 cell/ mm2 * Anterior chamber depth \< 2.5 mm * Diabetes mellitus type 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial cell density | 1 month | Corneal endothelial cell density measured using specular microscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central corneal thickness | 1 month | Central corneal thickness (in nm) measured using specular microscopy |
| Central macular thickness | 1 month | Central macular thickness (in nm) measure using optical coherence tomography |
| Anterior chamber cell reactions | 1 month | Anterior chamber cell reactions measured in Standardization of Uveitis Nomenclature (SUN) grading. Values consist of 0, trace, 1+, 2+, 3+, and 4+. Higher grading score means more inflammatory reaction which is worse. |
| Intraocular pressure | 1 month | Intraocular pressure (in mmHg) measured using automated non contact tonometer |
Countries
Indonesia
Outcome results
None listed