A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery.
OBJECTIVE
To compare intraoperative injection of triamcinolone and ciprofloxacin in a controlled-release system (DuoCat) with prednisolone and ciprofloxacin eye drops after cataract surgery.


METHODS
In this randomized, double-masked, controlled trial, a total of 135 patients undergoing cataract surgery were randomly allocated to two groups: 67 patients treated after surgery with prednisolone 1% and ciprofloxacin 3% eye drops four times daily (week 1), three times daily (week 2), twice daily (week 3), and once daily (week 4) and 0.3% ciprofloxacin drops four times daily (weeks 1 and 2), and 68 patients treated at the end of surgery with a sub-Tenon's injection of 25 mg triamcinolone and 2 mg ciprofloxacin in biodegradable microspheres. The patients were examined on postoperative days 1, 3, 7, 14, and 28. The main outcome measures were postoperative anterior chamber cell and flare, intraocular pressure (IOP), lack of anti-inflammatory response, and presence of infection.


RESULTS
No significant differences were observed between the groups in anterior chamber cell (P > 0.14) and flare (P > 0.02) at any postoperative visits. The mean (99% confidence interval) differences in IOP between the prednisolone and triamcinolone groups on days 1, 3, 7, 14, and 28 were -0.4 mm Hg (-2.1 to 1.3), 0.0 mm Hg (-1.4 to 1.3), 0.0 mm Hg (-1.1 to 1.1), -0.2 mm Hg (-1.1 to 0.8), and -0.1 mm Hg (-1.1 to 0.9), respectively. No patient had a postoperative infection.


CONCLUSIONS
One injection of DuoCat had a therapeutic response and ocular tolerance that were equivalent to conventional eye drops in controlling inflammation after cataract surgery. (ClinicalTrials.gov number, NCT00431028.).
Paganelli
Fernando
F
Hospital de Olhos de Araraquara, Araraquara, São Paulo, Brazil.
Cardillo
José A
JA
Melo
Luiz A S
LA
Lucena
David R
DR
Silva
Arnobio A
AA
Oliveira
Anselmo G
AG
Höfling-Lima
Ana L
AL
Nguyen
Quan Dong
QD
Kuppermann
Baruch D
BD
Belfort
Rubens
R
D000368:Aged; D000867:Anterior Chamber / Q000473:pathology; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D003238:Connective Tissue; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004337:Drug Carriers; D004359:Drug Therapy, Combination; D015818:Eye Infections, Bacterial / Q000517:prevention & control; D005260:Female; D006801:Humans; D007249:Inflammation / Q000517:prevention & control; D007267:Injections; D007429:Intraocular Pressure; D007430:Intraoperative Care; D019344:Lactic Acid; D019654:Lens Implantation, Intraocular; D008297:Male; D033401:Microscopy, Acoustic; D009887:Ophthalmoscopy; D018918:Phacoemulsification; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011183:Postoperative Complications / Q000517:prevention & control*; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D014606:Uveitis, Anterior / Q000517:prevention & control
D000890:Anti-Infective Agents; D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D002939:Ciprofloxacin; D011239:Prednisolone; D014222:Triamcinolone Acetonide