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Ophthalmology. 2016 Oct;123(10):2103-12. doi: 10.1016/j.ophtha.2016.06.032. Epub 2016 Aug 6.

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

Author information

1
Vold Vision, Fayetteville, Arkansas.
2
Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.
3
Wilmer Eye Institute, Baltimore, Maryland; King Khaled Eye Specialists Hospital, Riyadh, Saudi Arabia.
4
New England Eye Center, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts.
5
Glaucoma Clinic, University of California-San Francisco Medical Center, San Francisco, California.
6
Oregon Health & Science University, Portland, Oregon.
7
Atlanta Ophthalmology Associates, Atlanta, Georgia.
8
Transcend Medical, Inc., Menlo Park, California; University of California-San Francisco, San Francisco, California. Electronic address: sean@ianchulev.com.

Abstract

PURPOSE:

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.

PMID:
27506486
DOI:
10.1016/j.ophtha.2016.06.032
[Indexed for MEDLINE]

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