Retisert and Cataract Surgery in Patients With Severe Uveitis

NCT00570830 | Completed DMC

• 2 other identifiers: 91459145-06--10R0ER
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis.

Conditions

Intermediate Uveitis; Posterior Uveitis

Outcome Measures

Primary Outcomes (1)

• Preoperative and postoperative ocular inflammation

  up to 12 months postoperatively

Secondary Outcomes (1)

• visual acuity

  up to 12 months postoperatively

Study Arms (1)

1

OTHER

single armed case series in which all patients underwent the same treatment.

Device: Retisert (fluocinolone acetonide implant)

Interventions

Retisert (fluocinolone acetonide implant) DEVICE

Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.

Also known as: 1

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A visually significant cataract
• A history of recurrent noninfectious posterior uveitis or intermediate uveitis with or without iridocyclitis
• incomplete therapeutic response or treatment-limiting side effects to oral, periocular corticosteroid, and/or immunosuppressive agents
• VA of at least light perception; and
• Ability to comprehend informed consent and comply with follow-up examinations

You may not qualify if:

• An allergy to fluocinolone acetonide or any component of the delivery system
• A toxoplasmosis scar was present in the study eye,
• A peripheral retinal detachment (RD) in the area of the planned fluocinolone acetonide implant placement
• Required chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to treat non-ocular disease or if they tested positive for human immunodeficiency virus.
• Also excluded were female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 07710, United States

Location

Related Publications (3)

• Foster CS, Fong LP, Singh G. Cataract surgery and intraocular lens implantation in patients with uveitis. Ophthalmology. 1989 Mar;96(3):281-8. doi: 10.1016/s0161-6420(89)32898-3.

  PMID: 2629713 BACKGROUND

• Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.

  PMID: 16690128 BACKGROUND

• Chieh JJ, Carlson AN, Jaffe GJ. Combined fluocinolone acetonide intraocular delivery system insertion, phacoemulsification, and intraocular lens implantation for severe uveitis. Am J Ophthalmol. 2008 Oct;146(4):589-594. doi: 10.1016/j.ajo.2008.05.035. Epub 2008 Jul 17.

  PMID: 18639220 DERIVED

MeSH Terms

Conditions

Uveitis, Intermediate; Uveitis, Posterior

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases; Panuveitis

Study Officials

• Glenn J Jaffe, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 11, 2007
• Study Start: September 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: May 1, 2008
• Last Updated: September 3, 2014

Record last verified: 2008-08

Locations

US (1)