Risk of elevated intraocular pressure and glaucoma in patients with uveitis: results of the multicenter uveitis steroid treatment trial

Abstract

Objective: To report the 2-year incidence of raised intraocular pressure (IOP) and glaucomatous optic nerve damage in patients with uveitis randomized to either fluocinolone acetonide (FA) implants or systemic therapy. Secondarily, we sought to explore patient and eye characteristics associated with IOP elevation or nerve damage.

Design: A randomized, partially masked trial in which patients were randomized to either FA implants or systemic therapy.

Participants: Patients aged ≥ 13 years with noninfectious intermediate, posterior, or panuveitis active within the prior 60 days for which systemic corticosteroids were indicated were eligible.

Methods: Visual fields were obtained at baseline and every 12 months using the Humphrey 24-2 Swedish interactive threshold algorithm (SITA) fast protocol. Stereoscopic optic nerve photos were taken at baseline and at 3-, 6-, 12-, and 24-month follow-up visits. Masked examiners measured IOP at every study visit.

Main outcome measures: Glaucoma was diagnosed based on an increase in optic nerve cup-to-disc ratio with visual field worsening or increased cup-to-disc ratio alone, for cases where visual field change was not evaluable, because of missing data or severe visual field loss at baseline.

Results: Most patients were treated as assigned; among those evaluated for glaucoma, 97% and 10% of patients assigned to implant and systemic treatment, respectively, received implants. More patients (65%) assigned to implants experienced an IOP elevation of ≥ 10 mmHg versus 24% assigned to systemic treatment (P<0.001). Similarly, 69% of patients assigned to the implant required IOP-lowering therapy versus 26% in the systemic group (P<0.001). Glaucomatous optic nerve damage developed in 23% versus 6% (P<0.001) of implant and systemic patients, respectively. In addition to treatment assignment, black race, use of IOP-lowering medications, and uveitis activity at baseline were associated with incident glaucoma (P<0.05).

Conclusions: Implant-assigned eyes had about a 4-fold risk of developing IOP elevation of ≥ 10 mmHg and incident glaucomatous optic neuropathy over the first 2 years compared with those assigned to systemic therapy. Central visual acuity was unaffected. Aggressive IOP monitoring with early treatment (often including early filtration surgery) is needed to avoid glaucoma when vision-threatening inflammation requires implant therapy.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

Figure 1

CONSORT diagram; VF – visual field

Figure 2

Box plots of IOP measurements from eyes with uveitis during the trial by treatment assignment. Data for the Implant group are in black and data for the Systemic group are in grey. The middle bar of the boxes represents the median; the lower and upper ends of the boxes are the first and third quartiles, respectively. The whiskers represent values within 1.5 times the inter-quartile range from the upper or lower quartile (or the minimum and maximum if within 1.5 times the interquartile range of the quartiles) and data more extreme than the whiskers are plotted individually as outliers (circles for implant group and triangles for systemic group).

Figure 3

Kaplan-Meir curve of time from treatment initiation to increase in IOP≥10 mm Hg by treatment assignment among patients who received their assigned treatment. The numbers below the graph represent the number of patients in the risk set at each time point and, in parenthesis, the number of events that occurred within the 3 month time intervals. Abbreviations: IOP – intraocular pressure, IMP – Implant treatment assignment, SYS – Systemic treatment assignment