Table 2.
Mean IOP and Changes from Baseline at Each Visit (N=20)
| Screening | Baseline | Day 1 | Week 1 | Month 1 | Month 3 | Month 6 | |
|---|---|---|---|---|---|---|---|
| Number of eyes | 20 | 20 | 20 | 20 | 19 | 19 | 19 |
| IOP (mmHg) | |||||||
| Mean (SD) | 16.3 (3.6) | 23.5 (2.5) | 13.7 (3.2) | 19.3 (7.8) | 14.2 (2.3) | 14.7 (2.1) | 14.7 (2.4) |
| Mean (SD) change from baseline | – | – | 9.8 (3.9) | 4.2 (8.2) | 9.3 (2.9) | 8.8 (3.5) | 8.8 (3.2) |
| Mean (SD) % change from baseline | – | – | 41.1 (14.5) | 17.0 (33.8) | 39.2 (9.9) | 36.8 (11.4) | 36.9 (11.0) |
| Significance* | – | – | <0.001 | 0.035 | <0.0001 | <0.001 | <0.001 |
| Medications (n) | |||||||
| Mean (SD) | 2.0 (0.8) | 0 (0) | 0 (0) | 0.4 (0.8) | 1.0 (1.2) | 1.0 (1.1) | 1.1 (1.1) |
| Mean (SD) change from baseline | – | – | 2.0 (0.8) | 1.6 (1.0) | 1.0 (0.9) | 1.0 (0.9) | 0.9 (0.9) |
| Mean (SD) % change from baseline | – | – | 100 (0) | 81.7 (38.2) | 57.9 (48.2) | 56.1 (47.2) | 49.1 (47.6) |
| Significance* | – | – | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 |
Notes: *The p-value is for comparison of mean IOP at each time point to baseline. This is an ongoing study where data will be presented later. Data to be collected include IOP, IOP-lowering medications, and safety; and will be deidentified. These pooled results will be analyzed and shared in a manuscript at the one-year mark. No other study documents will be made available. This study complies with the Declaration of Helsinki and all subjects signed informed consent. The research was approved by Hospital Angeles Puebla ethics committee because it is an external committee. Clínica Láser does not have its own IRB.