Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02595359

Enrollment

1000

Registered

2015-11-03

Start date

2013-01-31

Completion date

2018-06-20

Last updated

2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophthalmitis

Keywords

endophthalmitis, antibiotic therapy, cataract surgery, prevention

Brief summary

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Detailed description

Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure. As endophthalmitis is an infection, it should be preventable by antibiotic treatment. Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively. The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Interventions

DRUGMoxifloxacin

Moxifloxacin intracameral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* Diagnosis of visually significant cataract

Exclusion criteria

* Has known allergies to moxifloxacin * Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason * Has a known history of a condition which causes an immuno-compromised host state

Design outcomes

Primary

Measure	Time frame
endothelial cell count	6-month; 1 year; 2 years

Secondary

Measure	Time frame
endophthalmitis incidence	1 month

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026