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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00431028
Other study ID # Duocat 001
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received February 1, 2007
Last updated March 6, 2008
Start date September 2005
Est. completion date March 2008

Study information

Verified date March 2008
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 140
Est. completion date March 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
slow delivery ciprofloxacin + triamcinolone
2 mg ciprofloxacin + 25mg triamcinolone

Locations

Country Name City State
Brazil Department of Ophthalmology, Federal University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anterior chamber cell Days 1, 3, 7, 14, and 28 after surgery No
Primary Anterior chamber flare Days 1, 3, 7, 14, and 28 after surgery No
Primary Intraocular pressure Days 1, 3, 7, 14, and 28 after surgery Yes
Primary Lack of anti-inflammatory response Days 1, 3, 7, 14, and 28 after surgery Yes
Primary Presence of infection Days 1, 3, 7, 14, and 28 after surgery Yes
Secondary Conjunctival hyperemia Days 1, 3, 7, 14, and 28 after surgery No
Secondary Spectacle corrected visual acuity Day 28 after surgery No
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