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Kazuhiko Mori, Yuji Yamamoto, Yoko Ikeda, Morio Ueno, Kojiro Imai, Chie Sotozono, Shigeru Kinoshita; Exploratory study of the bleb maintaining effects of tacrolimus 0.1% solution post trabeculectomy. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3749. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To investigate whether tacrolimus (Tc), an immunosuppressive drug which reportedly has efficacy against vernal keratoconjunctivitis characterized by conjunctival proliferative fibrosis, also inhibits proliferative change around the filtering bleb post trabeculectomy (TLE), thus effectively maintaining the bleb with good control of intraocular pressure (IOP).
In this single-blind, parallel-group comparative study, we evaluated patients with primary open-angle glaucoma (POAG) or pseudoexfoliation (PXF) glaucoma who underwent TLE with mitomycin C (0.04%, 5 minutes), with or without cataract surgery, at our department between November 2015 and October 2017, and who were randomly divided in 2 groups and treated with the administration of either Tc (Talimus®ophthalmic solution 0.1%) (Tc Group) or artificial tear (AT) (Mytear®ophthalmic solution) (Control Group) eye drops for 24 weeks starting from 10- to 14-days postoperative. IOP and the slit-lamp microscopy findings of the filtering bleb under the score of the Indiana Bleb Appearance Grading Scale were evaluated and compared between the 2 groups at 0-, 4-, 8-, 16-, and 24-weeks post initiation of eye-drop administration. Stratification was based on the presence or absence of simultaneous cataract surgery and glaucoma type (i.e., POAG or PXF glaucoma), and the Satterthwaite t test or the Mann-Whitney U test was used for statistical analysis, with a Pvalue of <0.05 considered statistically significant.
Of the 59 cases, there were 29 (18 males, 11 females; mean age: 68.9±7.8 years) in Tc Group and 30 (13 males, 17 females; mean age: 69.0±8.6 years) in the AT Group. Whole-case analysis showed no difference between the 2 groups in regard to IOP and IOP change at all timepoints post initiation of eye-drop administration, yet stratified analysis of the POAG phaco TLE cases (Tc Group: n=11, AT Group: n=10) showed that IOP and IOP change post administration tended to be lower in the Tc Group than in the AT Group at the 24-week timepoint (p=0.096, 0.119). Also, the morphological classification (height/width) of filtering blebs showed them to be significantly larger and wider in the Tc Group at the 4-, 8-, 16-, and 24-week timepoints (Mann-Whitney U test, p<0.05).
Our findings suggest that post TLE, Tc may have bleb maintaining effects, especially in POAG patients who undergo phaco TLE.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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