Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

Sponsor

Melva Louisa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05741632

Collaborator

(none)

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

35.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Moxifloxacin Ophthalmic Solution Drug: Levofloxacin Ophthalmic	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgeryFirst group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery

Masking:

Triple (Participant, 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.

Primary Purpose:

Treatment

Official Title:

Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moxifloxacin Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.	Drug: Moxifloxacin Ophthalmic Solution Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery Other Names: Molcin(R)
Active Comparator: Levofloxacin Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.	Drug: Levofloxacin Ophthalmic Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery Other Names: Cravit(R)

Arm

Intervention/Treatment

Experimental: Moxifloxacin

Subjects will receive 0.1 cc undiluted non preserved intracameral Moxifloxacin during cataract surgery.

Drug: Moxifloxacin Ophthalmic Solution

Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Other Names:

Molcin(R)

Active Comparator: Levofloxacin

Subjects will receive 0.1 cc undiluted non preserved intracameral Levofloxacin during cataract surgery.

Drug: Levofloxacin Ophthalmic

Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Other Names:

Cravit(R)

Outcome Measures

Primary Outcome Measures

Endothelial cell density [1 month]
Corneal endothelial cell density measured using specular microscopy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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