Table 5.
Complications by Neovascular Glaucoma (NVG) versus other strata (1, 2, 4).
| Complication | Year 3 N, Cumulative proportion (Standard Error)(SE) |
log-rank p-value |
|
|---|---|---|---|
| NVG | Other Diagnosis | ||
| Tube occlusion | 3 5.5% (3.2%) | 4, 2.3% (1.1%) | 0.31 |
| Choroidal effusion | 1 1.8% (1.7%) | 1, 0.6% (0.6%) | 0.42 |
| Suprachoroidal hemorrhage | 0 0.0% NA | 0 0.0% NA | NA |
| Endophthalmitis | 0 0.0% NA | 1 0.5% (0.5%) | 0.54 |
| Cystoid Macular Edema | 1 1.9% (1.9%) | 9 5.2% (1.7%) | 0.29 |
| Shallow Anterior Chamber | 2 6.1% (4.2%) | 2 1.5% (1.0%) | 0.13 |
| Hypotony maculopathy | 1 0.5% (0.5%) | 0 0.0% NA | 0.54 |
| Diplopia | 4 6.1% (3.0%) | 26 14.4% (2.6%) | 0.085 |
| Corneal edema, All | 2 5.1% (3.6%) | 27 17.8% (3.1%) | 0.039 |
| Tube-corneal touch | 3 5.4% (3.0%) | 5 3.0% (1.3%) | 0.42 |
| Corneal graft rejection | 0 0.0% NA | 9 5.4% (1.8%) | 0.079 |
| Band Keratopathy | 1 1.4% (1.4%) | 0 0.0% NA | 0.10 |
| Corneal neovascularization | 0 0.0% NA | 1 0.7% (0.7%) | 0.59 |
| Anterior Synechiae | 0 0.0% NA | 1 0.7% (0.7%) | 0.59 |
| Tube erosion | 1 2.0% (1.9%) | 2 1.2% (0.8%) | 0.74 |
| Encysted Bleb | 0 0.0% NA | 1 0.6% (0.6%) | 0.56 |
| Recurrent or persistent iritis | 2 3.5% (2.4%) | 9 5.2% (1.7%) | 0.55 |
| Phthisis bulbi | 4 7.8% (3.8%) | 1 0.5% (0.5%) | 0.004 |
| Hyphema | 4 5.9% (2.9%) | 0 0.0% NA | 0.001 |
| Vitreous hemorrhage | 6 10.2% (4.0%) | 0 0.0% NA | <0.001 |
| Pupillary membrane | 1 1.6% (1.6%) | 0 0.0% NA | 0.089 |
| Epiretinal membrane | 1 1.4% (1.4%) | 0 0.0% NA | 0.10 |
| Retinal Detachment | 4 6.4% (3.1%) | 0 0.0% NA | 0.001 |
| Corneal blood staining | 2 2.8% (2.0%) | 0 0.0% NA | 0.020 |
| Total Patients with Late Complications | 34 53.0% (6.5%) | 84 46.4% (3.8%) | 0.57 |
In the one year follow-up report, the complications of 4 eyes occurring after complications explant of the study device were included in percentages
Risk greater than 1.0 is associated with higher risk in NVG eyes, a risk less than 1.0 is associated with a higher risk in eyes with other diagnoses.
Cox proportional hazards model did not converge
After publication of the one year report, the Data and Safety Monitoring Committee decided that one case of endophthalmitis was due to a corneal transplant which occurred after implantation of the study shunt and that the necessity of performing the corneal transplant was due to pre-existing corneal disease and not the study shunt