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Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02770729
Recruitment Status : Terminated
First Posted : May 12, 2016
Last Update Posted : August 21, 2018
Information provided by (Responsible Party):
Mathias Violante Mélega, University of Campinas, Brazil

Brief Summary:
There has thus far been only one randomized and masked clinical trial in the world to evaluate the efficacy of the intraoperative intracameral injection of antibiotics with the objective of preventing endophthalmitis following cataract surgery. The ESCRS study from 2007 confirmed that the intracameral use of cefuroxime reduced the incidence of endophthalmitis approximately fivefold. Unlike in Europe, where this drug came to be widely used after the 2007 results, cefuroxime is not commercially available in Brazil. Many studies around the world have substituted cefuroxime with moxifloxacin, which is a drug that is easily found around the world in eye drop form. It is widely used in postoperative regimens in cases of ophthalmologic surgeries, and it is free of preservatives that are toxic to intraocular structures (corneal endothelial cells). Three studies (all respective) found that the intracameral use of moxifloxacin is safe and effective for preventing endophthalmitis following cataract surgery; however, no controlled, randomized, and masked clinical trials have been performed with this objective. If this trial confirms its hypothesis (a reduction in the incidence of endophthalmitis following cataract surgery) and if minimal side effects are reported, moxifloxacin may be an option for routine intracameral use during cataract surgery, thus reducing cases of endophthalmitis and consequent cases of blindness.

Condition or disease Intervention/treatment Phase
Endophthalmitis Drug: Moxifloxacin Drug: No injection of moxifloxacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Use of Intracameral Moxifloxacin for the Prevention of Acute Endophthalmitis Following Cataract Surgery: a Controlled and Randomized Clinical Trial
Actual Study Start Date : January 2017
Actual Primary Completion Date : February 2018
Actual Study Completion Date : May 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Intracameral moxifloxacin
Intracameral injection of 0.5% moxifloxacin at conclusion of cataract surgery (150 micrograms)
Drug: Moxifloxacin
Intracameral injection of moxifloxacin at conclusion of cataract surgery
Other Name: Vigamox

Sham Comparator: No injection of moxifloxacin
No injection of moxifloxacin at conclusion of cataract surgery
Drug: No injection of moxifloxacin
No intracameral injection of moxifloxacin at conclusion of cataract surgery
Other Name: No Injection

Primary Outcome Measures :
  1. Endophthalmitis incidence [ Time Frame: 45 days ]
    Endophthalmitis incidence in each group

Secondary Outcome Measures :
  1. Endothelial cell count [ Time Frame: 45 days ]
    Endothelial cell count loss in each group

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Diagnosis of visually significant cataract

Exclusion Criteria

  • Moxifloxacin allergy
  • Traumatic cataract with ocular perforation
  • Cataract surgery associated with other procedures, such as glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery
  • Signs of ocular or periocular infection
  • Advanced glaucoma
  • Severe dry eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02770729

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Mathias Violante Mélega
Campinas, São Paulo, Brazil, 13025-050
Sponsors and Collaborators
University of Campinas, Brazil
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Principal Investigator: Mathias V Mélega, MD University of Campinas

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Responsible Party: Mathias Violante Mélega, MD, University of Campinas, Brazil Identifier: NCT02770729    
Other Study ID Numbers: Moxi-Unicamp
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mathias Violante Mélega, University of Campinas, Brazil:
intracameral moxifloxacin
endothelial cell density
Additional relevant MeSH terms:
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Eye Infections
Eye Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs