Clincosm LogoSign in Get a demo

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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Terminated
CT.gov ID
NCT00431028
Collaborator
(none)
140
Enrollment
1
Location
1
Arm
30
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: slow delivery ciprofloxacin + triamcinolone
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
No Intervention: colirio

prednisolone 1% eye drops + ciprofloxacin 0,3% eye drops

Device: slow delivery ciprofloxacin + triamcinolone
2 mg ciprofloxacin + 25mg triamcinolone
Other Names:
  • ciprofloxacin
  • triamcinolona

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Anterior chamber cell [Days 1, 3, 7, 14, and 28 after surgery]

    2. Anterior chamber flare [Days 1, 3, 7, 14, and 28 after surgery]

    3. Intraocular pressure [Days 1, 3, 7, 14, and 28 after surgery]

    4. Lack of anti-inflammatory response [Days 1, 3, 7, 14, and 28 after surgery]

    5. Presence of infection [Days 1, 3, 7, 14, and 28 after surgery]

    Secondary Outcome Measures

    1. Conjunctival hyperemia [Days 1, 3, 7, 14, and 28 after surgery]

    2. Spectacle corrected visual acuity [Day 28 after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Federal University of Sao Paulo Sao Paulo Brazil 04023-062

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    • Principal Investigator: Fernando Paganelli, MD, Federal University of Sao Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00431028
    Other Study ID Numbers:
    • Duocat 001
    First Posted:
    Feb 2, 2007
    Last Update Posted:
    Mar 7, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    Cataract
    Endophthalmitis
    Antibiotics
    Anti-Inflammatory Agents
    Drug Delivery Systems
    Additional relevant MeSH terms:
    Bacterial Infections
    Cataract
    Inflammation
    Ciprofloxacin
    Triamcinolone

    Study Results

    No Results Posted as of Mar 7, 2008