Retisert and Cataract Surgery in Patients With Severe Uveitis

NCT ID: NCT00570830

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-05-31

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.

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.

Conditions

Intermediate Uveitis; Posterior Uveitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: OTHER

Retisert (fluocinolone acetonide implant)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

1

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Duke University Medical Center

Principal Investigators

Glenn J Jaffe, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 2629713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16690128 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18639220 (View on PubMed)

Other Identifiers

9145-06--10R0ER

Identifier Type: -

Identifier Source: secondary_id

9145

Identifier Type: -

Identifier Source: org_study_id