Retisert and Cataract Surgery in Patients With Severe Uveitis

Duke University

Status

Completed

Conditions

Posterior Uveitis

Intermediate Uveitis

Treatments

Device: Retisert (fluocinolone acetonide implant)

Study type

Interventional

Funder types

Other

Identifiers

NCT00570830

9145

9145-06--10R0ER

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Volunteers

No Healthy Volunteers

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.