TABLE 3.
Postoperative Ocular Adverse Events Occurring at 2% or Greater in the Study Eye, Overall Trial Population, Failed-Surgery Subgroup, MTMT Subgroup*
| Overall Trial Population N=72 | Failed-Surgery Subgroup N=61 | MTMT Subgroup N=11 | |
|---|---|---|---|
| Adverse Event† | No. Subjects (%) | No. Subjects (%) | No. Subjects (%) |
| Age-related macular degeneration | 1 (1.4) | 0 (0.0) | 1 (9.1) |
| Blepharitis | 3 (4.2) | 3 (4.9) | 0 (0.0) |
| Hyperemia | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| IOP increase ≥10 mm Hg vs. baseline IOP at ≥month 1 | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| IOP increase requiring oral medication | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| at >day 1 to ≤week 1 | 1 (1.4) | 1 (1.6) | 0 (0.0) |
| at ≥ month 1 | 1 (1.4) | 1 (1.6) | 0 (0.0) |
| IOP increase requiring surgical intervention | 3 (4.2) | 3 (4.9) | 0 (0.0) |
| at >week 1 to <month 1 | 1 (1.4) | 1 (1.6) | 0 (0.0) |
| at ≥month 1 | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| Intraocular inflammation after tube shunt surgery | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| Loss of best spectacle corrected visual acuity (BSCVA) of 2 lines or more at >30 d‡ | 6 (8.3) | 6 (9.8) | 0 (0.0) |
| Macular edema | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| Ocular hypotensive medication intolerance | 3 (4.2) | 3 (4.9) | 0 (0.0) |
| Ocular surface disease | 7 (9.7) | 7 (11.5) | 0 (0.0) |
| Perioperative inflammation | 5 (6.9) | 4 (6.6) | 1 (9.1) |
| Significant hyphema (ie, ≥10% of anterior chamber) | 3 (4.2) | 2 (3.3) | 1 (9.1) |
| Stent migration§ | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| Stent obstruction∥ | 2 (2.8) | 2 (3.3) | 0 (0.0) |
| Visual field loss ≥2.5 dB | 5 (6.9) | 4 (6.6) | 1 (9.1) |
Data from safety population for all groups.
In addition to the adverse events reported in Table 3, events that occurred at a rate of <2% included 1 case (1.4%) each of conjunctival erosion due to tube shunt, conjunctivitis, disc hemorrhage, hypotony (IOP <6 mm Hg) associated with clinically significant findings that occurred 1 day after tube shunt surgery, intraocular inflammation arising after the protocol’s specified medication regimen is complete, loss of BSCVA of 2 lines or more ≤30 days postoperative, ocular pain, posterior vitreous detachment, stye, subconjunctival hemorrhage, and transient hypotony.
Five AEs of BSCVA loss of 2 lines or more were ongoing at month 12.
One subject was reported with 2 events of stent migration. The PI acknowledged that the visualization was impaired during implantation of the 1:00 and 4:30 stents due to corneal arcus, striae, and external location-marking dye. The stent reported as implanted at 1:00 was identified in the 1:00 position via UBM (“imbedded deep beyond iris insertion”), and the stent reported as implanted at 4:30 was identified in the 7:30 position via both gonioscopy and UBM.
The 2 AEs of stent obstruction involved complete obstruction of 2 stents each. The investigators reported associated findings of significant hyphema in 1 case and preexisting and postoperative focal goniosynechiae in both cases. One case of stent obstruction resolved after treatment with pilocarpine, and 1 case was not treated and was ongoing at month 12. Both subjects experienced month 12 MDIOP reduction on the same medication regimen as preoperative.