Clinical trial NCT05741632: Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery
Official title: Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cataract
Keywords: Moxifloxacin
Levofloxacin
Cataract surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Ferron Par Pharmaceuticals
First posted: 2023-02-23
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First group will receive Moxifloxacin intracameral during surgery Second group will receive Levofloxacin intracameral during surgery
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelial cell density
timeFrame: 1 month
Secondary outcomes:
measure: Central corneal thickness
timeFrame: 1 month
measure: Central macular thickness
timeFrame: 1 month
measure: Anterior chamber cell reactions
timeFrame: 1 month
measure: Intraocular pressure
timeFrame: 1 month
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: RSCM Kirana
name: Arcci Pradessatama, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melega MV, Alves M, Cavalcanti Lira RP, Cardoso da Silva I, Ferreira BG, Assis Filho HL, Pedreira Chaves FR, Martini AAF, Dias Freire LM, Reis RD, Leite Arieta CE. Safety and efficacy of intracameral moxifloxacin for prevention of post-cataract endophthalmitis: Randomized controlled clinical trial. J Cataract Refract Surg. 2019 Mar;45(3):343-350. doi: 10.1016/j.jcrs.2018.10.044. Epub 2019 Jan 25.
citation: Chang DF, Prajna NV, Szczotka-Flynn LB, Benetz BA, Lass JH, O'Brien RC, Menegay HJ, Gardner S, Shekar M, Rajendrababu S, Rhee DJ. Comparative corneal endothelial cell toxicity of differing intracameral moxifloxacin doses after phacoemulsification. J Cataract Refract Surg. 2020 Mar;46(3):355-359. doi: 10.1097/j.jcrs.0000000000000064.
citation: Lucena NP, Pereira IMS, Gaete MIL, Ferreira KSA, Melega MV, Lira RPC. Intracameral moxifloxacin after cataract surgery: a prospective study. Arq Bras Oftalmol. 2018 Apr;81(2):92-94. doi: 10.5935/0004-2749.20180022.