Table 1.
Baseline Demographics and Clinical Characteristics of Patient Study Population (All-Implanted Analysis Set)
| Parameters | TFNT00 (N = 73) | |
|---|---|---|
| Age, years, n (%) | ||
| <65 | 48 (65.8) | |
| ≥65 | 25 (34.2) | |
| Mean ± SD | 58.5 ± 11.46 | |
| Median | 60 | |
| (minimum, maximum) | (28, 82) | |
| Sex, n (%) | ||
| Female | 39 (53.4) | |
| Male | 34 (46.6) | |
| Race, n (%) | ||
| Asian (Indian) | 73 (100.0) | |
| Clinical Characteristics, mean ± SD | First Eye (N = 73) | Second Eye (N = 68) |
| Monocular BCDVA (logMAR) | 0.43 ± 0.267 | 0.27 ± 0.147 |
| Sphere (D) | –0.87 ± 2.430 | –0.32 ± 1.937 |
| Cylinder (D) | 0.52 ± 0.611 | 0.40 ± 0.403 |
| MRSE (D) | –0.65 ± 2.344 | –0.16 ± 1.897 |
| Pupil size (mm) | 4.05 ± 0.786 | 4.08 ± 0.832 |
| Axial length (mm) | 23.31 ± 0.854 | 23.27 ± 0.857 |
| Anterior chamber depth (mm) | 3.29 ± 0.331 | 3.23 ± 0.330 |
| Corneal thickness (µm) | 525.4 ± 30.66 | 526.9 ± 32.79 |
| Lens thickness (mm) | 4.16 ± 0.416 | 4.25 ± 0.416 |
Note: Baseline refers to preoperative.
Abbreviations: BCDVA, best-corrected distance visual acuity; D, diopter; MRSE, manifest refraction spherical equivalent; N, number of eyes in the treatment group; SD, standard deviation.