Table 4.
Number, Cumulative Kaplan-Meier percent (standard error) of Late (> 3 months) Postoperative Complications in the Ahmed Baerveldt Comparison Study
| Complication | Year 3 N, Cumulative proportion (SE) | log-rank p-value |
Risk Ratio* |
95% confidence interval on risk ratio |
|
|---|---|---|---|---|---|
| Ahmed | Baerveldt | ||||
| Tube occlusion | 1, 0.8% (0.8%) | 6, 4.9% (1.9%) | 0.039 | 6.82 | 0.8 – 56.6 |
| Choroidal effusion | 0, 0.0% NA | 2, 1.7% (1.2%) | 0.15 | ** | ** |
| Suprachoroidal hemorrhage | 0, 0.0% NA | 0, 0.0% NA | NA | ** | ** |
| Endophthalmitis | 0, 0.0% NA | 1, 0.8% (0.8%) ‡ | 0.30 | ** | ** |
| Cystoid Macular Edema | 5, 4.1% (1.8%) | 5, 4.8% (1.8%) | 0.97 | 1.03 | 0.3 – 3.6 |
| Shallow Anterior Chamber | 1, 0.9% (0.9%) | 3, 3.3% (1.9%) | 0.27 | 3.31 | 0.3 – 31.8 |
| Hypotony maculopathy | 0, 0.0% NA | 1, 0.8% (0.8%) | 0.30 | ** | ** |
| Diplopia | 16, 11.9% (2.8%) | 14, 11.2% (2.8%) | 0.84 | 0.93 | 0.5 – 1.9 |
| Corneal edema, All | 14, 12.4% (3.1%) | 15, 15.7% (3.7%) | 0.51 | 1.3 | 0.6 – 2.7 |
| likely attributable to GDI | 7, 6.4% (2.3%) | 9, 10.1% (3.2%) | 0.42 | 1.50 | 0.6 – 4.0 |
| Tube-corneal touch | 4, 3.2% (1.6%) | 4, 3.5% (1.7%) | 0.88 | 1.12 | 0.3 – 4.5 |
| Corneal graft rejection | 4, 3.5 (1.7%) | 5, 4.6% (2.0%) | 0.71 | 1.29 | 0.3 – 4.8 |
| Band Keratopathy | 0, 0.0% NA | 1, 0.8% (0.8%) | 0.31 | ** | ** |
| Corneal neovascularization | 0, 0.0% NA | 1, 1.0% (1.0%) | 0.33 | ** | ** |
| Tube erosion | 2, 1.5% (1.1%) | 1, 0.9% (0.9%) | 0.61 | 0.54 | 0.1 – 6.0 |
| Encysted Bleb | 1, 0.9% (0.9%) | 0, 0.0% NA | 0.32 | ** | ** |
| Recurrent or persistent iritis | 6, 5.1% (2.0%) | 5 4.4% (1.9%) | 0.81 | 0.87 | 0.3 – 2.8 |
| Phthisis bulbi | 0, 0.0% NA | 5, 4.6% (2.0% | 0.023 | ** | ** |
| Hyphema | 2, 1.5% (1.1%) | 2, 1.6% (1.1%) | 0.97 | 1.04 | 0.1 – 7.4 |
| Vitreous hemorrhage | 3, 2.7% (1.5%) | 3, 2.5% (1.5%) | 0.96 | 1.04 | 0.2 – 5.2 |
| Pupillary membrane | 1, 0.8% (0.8%) | 0, 0.0% NA | 0.33 | ** | ** |
| Epiretinal membrane | 0, 0.0% NA | 1, 0.8% (0.8) | 0.33 | ** | ** |
| Retinal Detachment | 2, 1.6% (1.1%) | 2, 1.7% (1.2%) | 0.98 | 1.02 | 0.1 – 7.2 |
| Corneal blood staining | 0, 0.0% NA | 2, 1.6% (1.1%) | 0.15 | ** | ** |
| Anterior Synechiae | 0, 0.0% NA | 1, 1.0% (1.0%) | 0.33 | ** | ** |
| Total Patients with Late Complications | 55, 44.7% (4.6%) | 63, 51.5% (4.6%) | 0.13 | 1.32 | 0.9 – 1.9 |
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 eyes randomized to Baereldt Glaucoma Implant, a risk less than 1.0 is associated with a higher risk in eyes randomized to Ahmed Glaucoma Valve.
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
SE = Standard Error, NA = Not applicable