Table 3.
FDA guidelines for the approval of excimer lasers
| Clinical endpoint | FDA criteria (%) | Current study | ||
|---|---|---|---|---|
| 3 months post-ENH (%) | 12 months post-ENH (%) | |||
| Safety | % of treated eyes with each ocular SAE type | < 1 | 0.6 | 0.8 |
| % of eyes with loss of ≥ 2 lines of CDVA | < 5 | 0.6 | 0.8 | |
| % of eyes with preoperative CDVA of 20/20 or better with a postoperative CDVA worse than 20/40 | < 1 | 0.6 | 0 | |
| % of eyes with > 2.00 D of induced MRC at refractive stability compared to baseline | < 5 | 0 | 0 | |
| Stability | % of eyes with a change of ≤ 1.00 D in MRSE and MRC between 2 refractions, performed at 1 and 3 months postoperatively, or over a ≥ 3-month period thereafter | ≥ 95 | 96 | 98 |
| Efficacy | % of eyes achieving UDVA of 20/40 or better for eyes with CDVA of 20/20 or better preoperatively | ≥ 85 | 99 | 99 |
| Predictability | % of eyes achieving MRSE within ± 0.50 D of the intended outcome | ≥ 50 | 88 | 86 |
| % of eyes achieving MRSE within ± 1.00 D of the intended outcome | ≥ 75 | 98 | 98 | |
ENH enhancement, UDVA uncorrected distance visual acuity, CDVA corrected distance visual acuity, SAE serious adverse events, MRC manifest refractive cylinder, MRSE manifest refraction spherical equivalent, D diopter