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Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery

Phase I/II Comparative Study of a Single Intraoperative Sub-Tenon's Capsule Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System Versus 1% Prednisolone and 0.3% Ciprofloxacin Eyedrops for Cataract Surgery

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00431028
Enrollment
140
Registered
2007-02-02
Start date
2005-09-30
Completion date
2008-03-31
Last updated
2008-03-07

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

Conditions

Bacterial Infections, Inflammation

Keywords

Cataract, Endophthalmitis, Antibiotics, Anti-Inflammatory Agents, Drug Delivery Systems

Brief summary

The purpose of this study is to compare one intraoperative sub-Tenon's capsule injection of triamcinolone and ciprofloxacin in a biodegradable controlled-release system with conventional prednisolone and ciprofloxacin eye drops to treat ocular inflammation and for infection prophylaxis after cataract surgery.

Detailed description

Topical steroids effectively control ocular inflammation, but are associated with the well-recognized problems of patient compliance. Injection of depot corticosteroids into sub-Tenon's capsule is an established method of treating various ocular inflammatory diseases. Its prolonged therapeutic effect has provided the ophthalmologist with an alternative tool for the treatment of different diseases that may be extended to the surgical arena to modulate postoperative inflammation. The use of topical antibiotic agents poses unique and challenging hurdles for drug delivery, especially because recent reports have suggested that the incidence of endophthalmitis may be increasing. Exploiting the permeability of the sclera, subconjunctival routes may offer a more promising alternative for enhanced drug delivery and tissue targeting compared with topical routes. In theory, the combination of an antibiotic with a steroid in a controlled-release system delivered transscleral could be feasible after cataract surgery to achieve several clinical objectives, i.e., eliminate topical medications, enhance patient compliance, improve drug bioavailability, and protect the patient from infection.

Interventions

DEVICEslow delivery ciprofloxacin + triamcinolone

2 mg ciprofloxacin + 25mg triamcinolone

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with uncomplicated, senile cataract * Best-corrected visual acuity (VA) of 20/100 or better in the fellow eye

Exclusion criteria

* Patients in use of oral or topical anti-inflammatory agents * History of steroid-induced ocular hypertension * Hypermature cataracts * Previous ocular surgery * Preexisting uveitis * Diabetic retinopathy * Glaucoma * Corneal disease

Design outcomes

Primary

MeasureTime frame
Anterior chamber flareDays 1, 3, 7, 14, and 28 after surgery
Lack of anti-inflammatory responseDays 1, 3, 7, 14, and 28 after surgery
Presence of infectionDays 1, 3, 7, 14, and 28 after surgery
Anterior chamber cellDays 1, 3, 7, 14, and 28 after surgery
Intraocular pressureDays 1, 3, 7, 14, and 28 after surgery

Secondary

MeasureTime frame
Spectacle corrected visual acuityDay 28 after surgery
Conjunctival hyperemiaDays 1, 3, 7, 14, and 28 after surgery

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026