TY - JOUR
T1 - Incidence and Outcome of Uveitic Glaucoma in Eyes With Intermediate, Posterior, or Panuveitis Followed up to 10 Years After Randomization to Fluocinolone Acetonide Implant or Systemic Therapy
AU - Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study Research Group
AU - Kempen, John H.
AU - Van Natta, Mark L.
AU - Friedman, David S.
AU - Altaweel, Michael M.
AU - Ansari, Husam
AU - Dunn, James P.
AU - Elner, Susan G.
AU - Holbrook, Janet T.
AU - Lim, Lyndell L.
AU - Sugar, Elizabeth A.
AU - Jabs, Douglas A.
N1 - Funding Information:
Funding Support: This study was supported by National Eye Institute (Bethesda, Maryland) Collaborative Agreements U10EY014655 (Dr. Jabs), U10EY014660 (Dr. Holbrook), and U10EY014656 (Dr. Altaweel). Additional support was provided by Research to Prevent Blindness (New York, New York). Bausch & Lomb provided support to the study in the form of donation of fluocinolone implants for patients randomized to implant therapy who were uninsured or otherwise unable to pay for implants, or were located at a site where implants could not be purchased (eg, in the United Kingdom). Representatives of the National Eye Institute participated in the conduct of the study, including the study design and the collection, management, analysis, and interpretation of the data, as well as in the review and approval of this manuscript. None of the other sponsors had any role in the design and conduct of the report; collection, management, analysis, and interpretation of the data; or in the preparation, review, and approval of this manuscript. Financial Disclosures: Michael M. Altaweel reports grant/contract to institutional employer from the National Eye Institute .
Funding Information:
Janet T. Holbrook is a consultant-DSMC member for Gilead and reports grant/contract to institutional employer from the National Eye Institute , National Heart, Lung, and Blood Institute , American Lung Association , and the Patient-Centered Outcomes Research Institute . Douglas A. Jabs reports grant/contract to institutional employer from the National Eye Institute . John H. Kempen is a consultant-DSMC Chair for Gilead and reports grant/contract to institutional employer from the National Eye Institute , Sight for Souls, and Christian Blind Mission International . Lyndell L. Lim receives consultancy/lecture fees from Allergan, Bayer, Novartis, and Specsavers and grants from Bayer and National Health and Medical Council (Australia). Elizabeth A. Sugar reports grant/contract to institutional employer from the National Eye Institute . The remaining authors indicate no financial support or conflicts of interest. Conflict of interest disclosures for the remainder of the MUST Research Group are on file at the MUST Coordinating Center. All authors attest that they meet the current ICMJE criteria for authorship.
PY - 2020/11
Y1 - 2020/11
N2 - Purpose: To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, “implant”) therapy. Design: Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort. Methods: Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome. Results: Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P <.001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P =.001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%). Conclusions: The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.
AB - Purpose: To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, “implant”) therapy. Design: Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort. Methods: Patients with intermediate, posterior, or panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome. Results: Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P <.001). Adjustment for intraocular pressure (IOP) elevation during follow-up only partially mitigated the association of implant treatment with glaucoma incidence: HR = 3.1 (95% CI 1.6, 6.0); P =.001. Among 112 eyes of 83 patients developing glaucoma, the 5-year cumulative incidence following diagnosis of sustained (2 or more consecutive visits) worsening of mean deviation by ≥6 dB was 20% (95% CI 12%, 33%); 5-year cumulative incidence of sustained worsening of cup-to-disc ratio by ≥0.2 was 26% (95% CI 17%, 39%). Conclusions: The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.
UR - http://www.scopus.com/inward/record.url?scp=85090846444&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85090846444&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2020.06.038
DO - 10.1016/j.ajo.2020.06.038
M3 - Article
C2 - 32628922
AN - SCOPUS:85090846444
VL - 219
SP - 303
EP - 316
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
ER -