Retisert and Cataract Surgery in Patients With Severe Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570830
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : September 3, 2014
Information provided by:
Duke University

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.

Condition or disease Intervention/treatment Phase
Intermediate Uveitis Posterior Uveitis Device: Retisert (fluocinolone acetonide implant) Not Applicable

Detailed Description:
Cataracts are common in eyes with uveitis. It results from inflammation or the use of topical or systemic steroids. Cataract surgery can cause an unusually severe inflammatory response, abnormal or excessive bleeding, and unexpected postoperative IOP responses such as hypertension or hypotony. Previous studies showed that successful outcome is preoperative and postoperative control of intraocular inflammation by topical, periocular, and systemic steroidal or immunosuppressive agents. In patients with severe posterior uveitis, periocular and intravitreal injections often provide only transient effects and are associated with complications such as hemorrhage, retinal detachment and endophthalmitis. Oral corticosteroid therapy are also associated with side effects to multiple organ systems in the body. A novel technology that delivers corticosteroid therapy linearly via an intravitreal, polymer-coated, sustained release implant has been developed and FDA approved to treat severe posterior segment uveitis. FA implantation effectively controls inflammation over an extended period of time in a complicated group of patients with posterior and/or panuveitis and allows reduced immunosuppression. We hope to determined whether this implant, a fluocinolone acetonide sustained drug delivery system (FA), can safely suppress postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis. We hypothesize that combining the implant with cataract surgery will provide better surgical outcomes by suppressing inflammation during the postoperative period. By reviewing our own surgical data at the Duke Eye Center, we intend to primarily focus on the safety and effectiveness of this surgical procedure.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis
Study Start Date : September 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : May 2008

Arm Intervention/treatment
single armed case series in which all patients underwent the same treatment.
Device: Retisert (fluocinolone acetonide implant)
Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.
Other Name: 1

Primary Outcome Measures :
  1. Preoperative and postoperative ocular inflammation [ Time Frame: up to 12 months postoperatively ]

Secondary Outcome Measures :
  1. visual acuity [ Time Frame: up to 12 months postoperatively ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00570830

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 07710
Sponsors and Collaborators
Duke University
Principal Investigator: Glenn J Jaffe, MD Duke University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Glenn J Jaffe, MD, Duke University Medical Center Identifier: NCT00570830     History of Changes
Other Study ID Numbers: 9145
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: August 2008

Additional relevant MeSH terms:
Pars Planitis
Uveitis, Posterior
Uveitis, Intermediate
Uveal Diseases
Eye Diseases
Choroid Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs