Adverse events and second surgical interventions (n=225)
| N (%) | |
| Adverse events | |
| Microstent obstruction | 23 (10.2) |
| IOP ≥10 mm Hg vs baseline | 20 (8.9)* |
| Retinal complication | 10 (4.4) |
| Loss of ≥2 lines of BCVA | 6 (2.7) |
| Visual field loss | 4 (1.8) |
| CyPass endothelial touch | 4 (1.8) |
| Hyphema | 3 (1.3) |
| Dry eye syndrome | 3 (1.3) |
| Anterior chamber inflammation/uveitis | 2 (0.9) |
| CyPass malposition | 2 (0.9) |
| Hypotony | 1 (0.4) |
| Conjunctivitis | 1 (0.4) |
| Herpes keratitis | 1 (0.4) |
| Band keratopathy | 1 (0.4) |
| Focal corneal stromal oedema | 1 (0.4) |
| Progression of corneal oedema | 1 (0.4) |
| Opacification of anterior lens capsule | 1 (0.4) |
| Plateau iris syndrome | 1 (0.4) |
| Secondary surgical interventions | |
| Secondary glaucoma surgery | 71 (31.6)† |
| Trabeculectomy | 33 (14.7) |
| Second microstent implantation | 13 (5.8) |
| Cyclophotocoagulation | 10 (4.4) |
| Tube/shunt implant | 5 (2.2) |
| Deep sclerectomy | 4 (1.8) |
| Other MIGS implant | 4 (1.8) |
| Laser (trabeculoplasty or iridotomy) | 3 (1.3) |
| Microstent obstruction lysis | 3 (1.3) |
| Microstent repositioning | 2 (0.9) |
| Microstent explantation | 2 (0.9)‡ |
| Cataract surgery | 19 (8.4) |
| Other | 8 (3.6) |
*Including 11 eyes that were phakic and 9 that were pseudophakic after CyPass implantation. Of the 11 phakic eyes, 1 had a history of narrow angle glaucoma, 1 had a history of secondary open angle glaucoma and 1 had undergone previous incisional glaucoma surgery. Of the nine pseudophakic eyes, six had undergone a previous glaucoma procedure, including four with previous incisional glaucoma surgery, with one of the latter having a history of congenital glaucoma.
†Including one eye that underwent two secondary glaucoma surgeries within 1 month, laser peripheral iridotomy and trabeculoplasty .
‡Including from one eye with persistent corneal oedema and from one eye in conjunction with trabeculectomy for additional IOP control.
§
BCVA, best-corrected visual acuity; IOP, intraocular pressure; MIGS, minimally invasive glaucoma surgery.