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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02595359
Other study ID # 0001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2013
Est. completion date June 20, 2018

Study information

Verified date April 2019
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date June 20, 2018
Est. primary completion date June 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Moxifloxacin
Moxifloxacin intracameral

Locations

Country Name City State
Brazil UFPE Ophthalmology Recife PE

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary endothelial cell count 6-month; 1 year; 2 years
Secondary endophthalmitis incidence 1 month
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Completed NCT01323868 - Endogenous Endophthalmitis in the Inpatient Setting N/A
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Terminated NCT02770729 - Evaluation of Efficacy and Safety of Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis. Phase 3
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