Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

This study is currently recruiting participants.

Verified by Federal University of São Paulo, May 2006

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00331084

Purpose

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Condition	Intervention
Inflammation Following Cataract Surgery	Drug: antibiotic/steroid combination

MedlinePlus related topics: Antibiotics Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

day 15 evaluation of anterior chamber

Secondary Outcome Measures:

day 15 evaluation of anterior chamber, ocular pain, physician´s follow-up impression of inflammatory reaction score

Estimated Enrollment:	132
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients having cataract surgery

Exclusion Criteria:

Uncontrolled glaucoma or intraocular hypertension;
Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
A history of chronic or recurrent ocular inflammatory disease;
Uncontrolled diabetes mellitus and diabetic retinopathy ;
Patients with sight in a single eye;
Iris atrophy in the eye to be operated;
Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
Known or suspected allergy or hypersensitivity to any component of study medication;
A history or any other evidence of severe systemic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331084

Contacts

Contact: Cristina Muccioli, MD

5511-50852027

cmucciol@uol.com.br

Locations

Brazil, SP
Dept of Opthalmology - Rua Botucatu 824	Recruiting
São Paulo, SP, Brazil, 04023-062
Contact: Cristina Muccioli, MD 5511-50852027 cmucciol@uol.com.br
Principal Investigator: Cristina Muccioli, MD

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Rubens Belfort Jr, MD, PhD

Federal University of São Paulo

More Information

Study ID Numbers:	BRA-05-01
Study First Received:	May 25, 2006
Last Updated:	May 26, 2006
ClinicalTrials.gov Identifier:	NCT00331084
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:

prevention of post inflammation in cataract surgery

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009