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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05741632
• Other study ID #: 22-10-1262
• Secondary ID: KET-1303/UN2.F1/
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Moxifloxacin Ophthalmic Solution
Moxifloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery
• Levofloxacin Ophthalmic
Levofloxacin solution 0.1 cc undiluted, self preserved, injected into intracamera at the end of cataract surgery

Locations

Country	Name	City	State
Indonesia	Fakultas Kedokteran Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Ferron Par Pharmaceuticals

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial cell density	Corneal endothelial cell density measured using specular microscopy	1 month
Secondary	Central corneal thickness	Central corneal thickness (in nm) measured using specular microscopy	1 month
Secondary	Central macular thickness	Central macular thickness (in nm) measure using optical coherence tomography	1 month
Secondary	Anterior chamber cell reactions	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.	1 month
Secondary	Intraocular pressure	Intraocular pressure (in mmHg) measured using automated non contact tonometer	1 month