Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma and Cataracts

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• 作者：Steven Vold ; MD¹ ; Iqbal Ike K. Ahmed ; MD² ; E. Randy Craven ; MD³ ; ⁴ ; Cynthia Mattox ; MD⁵ ; Robert Stamper ; MD⁶ ; Mark Packer ; MD⁷ ; Reay H. Brown ; MD⁸ ; Tsontcho Ianchulev ; MD ; MPH⁹ ; ¹⁰ ; ^{sean@ianchulev.com" class="auth_mail" title="E-mail the corresponding author} ; for the CyPass Study Group^&lowast ;
• 关键词：AE ; adverse event ; BCVA ; best-corrected visual acuity ; CI ; confidence interval ; FDA ; Food and Drug Administration ; IOL ; intraocular lens ; IOP ; intraocular pressure ; ITT ; intention-to-treat ; MIGS ; microinvasive glaucoma surgery ; OAG ; open-angle glaucoma ; POAG ; primary open-angle glaucoma ; PP ; per-protocol ; RCT ; randomized controlled trial
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：123
• 期：10
• 页码：2103-2112
• 全文大小：1696 K

文摘

We evaluated 2-year safety and efficacy of supraciliary microstenting (CyPass Micro-Stent; Transcend Medical, Inc., Menlo Park, CA) for treating mild-to-moderate primary open-angle glaucoma (POAG) in patients undergoing cataract surgery.

Design

Multicenter (24 US sites), interventional randomized clinical trial (RCT) (ClinicalTrials.gov identifier, NCT01085357).

Participants

Subjects were enrolled beginning July 2011, with study completion in March 2015. Subjects had POAG with mean diurnal unmedicated intraocular pressure (IOP) 21–33 mmHg and were undergoing phacoemulsification cataract surgery.

Methods

After completing cataract surgery, subjects were intraoperatively randomized to phacoemulsification only (control) or supraciliary microstenting with phacoemulsification (microstent) groups (1:3 ratio). Microstent implantation via an ab interno approach to the supraciliary space allowed concomitant cataract and glaucoma surgery.

Main Outcome Measures

Outcome measures included percentage of subjects achieving ≥20% unmedicated diurnal IOP lowering versus baseline, mean IOP change and glaucoma medication use, and ocular adverse event (AE) incidence through 24 months.

Results

Of 505 subjects, 131 were randomized to the control group and 374 were randomized to the microstent group. Baseline mean IOPs in the control and microstent groups were similar: 24.5±3.0 and 24.4±2.8 mmHg, respectively (P > 0.05); mean medications were 1.3±1.0 and 1.4±0.9, respectively (P > 0.05). There was early and sustained IOP reduction, with 60% of controls versus 77% of microstent subjects achieving ≥20% unmedicated IOP lowering versus baseline at 24 months (P = 0.001; per-protocol analysis). Mean IOP reduction was ↓7.4 mmHg for the microstent group versus ↓5.4 mmHg in controls (P < 0.001), with 85% of microstent subjects not requiring IOP medications at 24 months. Mean 24-month medication use was 67% lower in microstent subjects (P < 0.001); 59% of control versus 85% of microstent subjects were medication free. Mean medication use in controls decreased from 1.3±1.0 drugs at baseline to 0.7±0.9 and 0.6±0.8 drugs at 12 and 24 months, respectively, and in the microstent group from 1.4±0.9 to 0.2±0.6 drugs at both 12 and 24 months (P < 0.001 for reductions in both groups at both follow-ups vs. baseline). No vision-threatening microstent-related AEs occurred. Visual acuity was high in both groups through 24 months; >98% of all subjects achieved 20/40 best-corrected visual acuity or better.

Conclusions

This RCT demonstrated safe and sustained 2-year reduction in IOP and glaucoma medication use after microinterventional surgical treatment for mild-to-moderate POAG.