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D. Lankaranian, R. Patel, M.R. Moster, S. Wizov, H.S. Alvim, J.F. Lopes, M. Tong, G.L. Spaeth; A Randomized Prospective Clinical Trial of the Efficacy of Cyclosporine Ophthalmic Emulsion 0.05% Following Trabeculectomy With Antimetabolite . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5486.
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© ARVO (1962-2015); The Authors (2016-present)
To verify usefulness of post–operative topical cyclosporine 0.05% (Restasis®) in antimetabolite augmented glaucoma filtering surgery
In a randomized, prospective, double–masked clinical trial, 44 glaucoma patients scheduled for glaucoma surgery were enrolled. Eligible patients were systematically randomized into 2 groups before surgery: control (artificial tear) and treatment group (CsA). The "Ocular Surface Disease Index (ODSI)" questionnaire was administered and Schirmer tear test I (STT1) was measured before and after surgery. Following surgery, patients started the study drops (BID) and continued for 6 months. The conjunctiva was biopsied at the time of surgery and 6 months later for immunohistopathologic evaluation. Major outcome measures were surgical success, bleb appearance, change in IOP, STT1, OSDI, and conjunctival inflammation.
20 controls and 19 treatment patients completed the study. Average age for treatment group was 62 ± 15, and 67 ±15 for controls (p=0.6). First–time trabeculectomy was the most frequent surgery followed by "triple procedure". Baseline IOP in treatment and control groups was 25 ±12 and 26 ±10 mmHg respectively (p= 0.73). Mean amount of decrease in IOP 6 months following surgery was 10 ± 12 mmHg (p= 0.002) in treatment group and 11 ± 11 mmHg (p= 0.000) in control group. Change in mean IOP was not significantly different between groups. The mean difference in STT1 6 months after surgery between control group (–2.13 ± 7.25, p= 0.22) and treatment group (2.90 ± 9.64, p= 0.20) was not significant. Baseline OSDI scores for control and treatment groups were 31 ±22 and 28 ±23 respectively (p= 0.68). Mean decrease in OSDI was 14 ±17 in treatment group (p=0.002) and 8 ±15 (p= 0.024) in control group. The difference between groups was significant after 6 months (p=0.005). There was no difference in conjunctival hyperemia between two groups at any interval (p>0.69). Success rate in treatment group was 89.5% (68.4% complete and 21.1% qualified) compared to success rate of 95% (90% complete, and 5% qualified) in the controls.
Application of CsA following surgery did not improve the success rate or final IOP following antimetabolite–augmented filtering surgery. These findings contradict previous studies showing beneficial effects of intra–operatively applied CsA. Possible explanations for these findings will be presented.
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