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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colirio | No Intervention | prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| slow delivery ciprofloxacin + triamcinolone | Device | 2 mg ciprofloxacin + 25mg triamcinolone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior chamber cell | Days 1, 3, 7, 14, and 28 after surgery | |
| Anterior chamber flare | Days 1, 3, 7, 14, and 28 after surgery | |
| Intraocular pressure | Days 1, 3, 7, 14, and 28 after surgery | |
| Lack of anti-inflammatory response | Days 1, 3, 7, 14, and 28 after surgery | |
| Presence of infection | Days 1, 3, 7, 14, and 28 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival hyperemia | Days 1, 3, 7, 14, and 28 after surgery | |
| Spectacle corrected visual acuity | Day 28 after surgery |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Paganelli, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Federal University of Sao Paulo | São Paulo | São Paulo | 04023-062 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19234342 | Derived | Paganelli F, Cardillo JA, Melo LA Jr, Lucena DR, Silva AA Jr, Oliveira AG, Hofling-Lima AL, Nguyen QD, Kuppermann BD, Belfort R Jr; Brazilian Ocular Pharmacology and Pharmaceutical Technology Research Group. A single intraoperative sub-tenon's capsule injection of triamcinolone and ciprofloxacin in a controlled-release system for cataract surgery. Invest Ophthalmol Vis Sci. 2009 Jul;50(7):3041-7. doi: 10.1167/iovs.08-2920. Epub 2009 Feb 21. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001424 | Bacterial Infections |
| D002386 | Cataract |
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D015817 | Eye Infections |