Retisert and Cataract Surgery in Patients With Severe Uveitis
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Purpose
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 | Intervention |
|---|---|
|
Intermediate Uveitis Posterior Uveitis |
Device: Retisert (fluocinolone acetonide implant) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Preoperative and postoperative ocular inflammation [ Time Frame: up to 12 months postoperatively ] [ Designated as safety issue: Yes ]
- visual acuity [ Time Frame: up to 12 months postoperatively ] [ Designated as safety issue: No ]
| Enrollment: | 21 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 07710 | |
| Principal Investigator: | Glenn J Jaffe, MD | Duke University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Glenn J Jaffe, MD, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00570830 History of Changes |
| Other Study ID Numbers: | 9145-06--10R0ER |
| Study First Received: | December 10, 2007 |
| Last Updated: | August 13, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Uveitis Chorioretinitis Uveitis, Intermediate Pars Planitis Uveitis, Posterior Uveal Diseases Eye Diseases Retinitis Retinal Diseases Choroiditis |
Choroid Diseases Panuveitis Fluocinolone Acetonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013