Table 1.
Participant and Study Eye Characteristics Overall and by Training and Test Data Subsets
| Protocol O Overall | Protocol O Train Data | Protocol O Test Data | CADME Data | |
|---|---|---|---|---|
| No. of participants | 107 | 75 | 32 | 37 |
| Sex, n (%) | ||||
| Female | 51 (48) | 35 (47) | 16 (50) | 12 (32) |
| Male | 56 (52) | 40 (53) | 16 (50) | 25 (68) |
| Race/ethnicity, n (%) | ||||
| Asian | 3 (3) | 2 (3) | 1 (3) | 1 (3) |
| Black/African American | 38 (36) | 25 (33) | 13 (41) | 1 (3) |
| Hispanic or Latino | 3 (3) | 2 (3) | 1 (3) | 0 |
| White | 63 (59) | 46 (61) | 17 (53) | 34 (92) |
| Age, years | ||||
| Mean (SD) | 62.7 (10.3) | 62.2 (9.7) | 63.9 (11.7) | 63.5 (9.7) |
| Median (IQR) | 63 (57 to 70) | 63 (57 to 69) | 68 (57 to 72) | 62 (58 to 68) |
| Diabetes type, n (%) | ||||
| Type 1 | 8 (7) | 6 (8) | 2 (6) | 6 (16) |
| Type 2 | 99 (93) | 69 (92) | 30 (94) | 31 (84) |
| Duration of diabetes, years | ||||
| Mean (SD) | 16.7 (9.9) | 17.1 (9.5) | 15.6 (10.8) | 13.1 (9.3) |
| Median (IQR) | 16 (10 to 22) | 16 (10 to 22) | 15 (8 to 22) | 12 (5 to 18) |
| Insulin used, n (%) | ||||
| No | 39 (36) | 26 (35) | 13 (41) | 19 (51) |
| Yes | 68 (64) | 49 (65) | 19 (59) | 18 (48) |
| Study eyes, n (%) | ||||
| Bilateral | 80 (75) | 56 (75) | 24 (75) | 0 |
| Unilateral | 27 (25) | 19 (25) | 8 (25) | 37 (100) |
| No. of eyes | 187 | 131 | 56 | 37 |
| Visual acuity, n (%) | ||||
| ≥20/40 | 124 (66) | 88 (67) | 36 (64) | 0 |
| 20/50–20/100 | 46 (25) | 33 (25) | 13 (23) | 19 (51) |
| ≤20/100 | 17 (9) | 10 (8) | 7 (13) | 18 (48) |
| Lens status, n (%) | ||||
| PC IOL | 75 (40) | 47 (36) | 28 (50) | 0 |
| Phakic | 112 (60) | 84 (64) | 28 (50) | 37 (100) |
| Mean of CST test-retest on Spectralis, µm | ||||
| Mean (SD) | 386 (111) | 383 (99) | 394 (135) | NA |
| Median (IQR) | 361 (305 to 432) | 365 (307 to 432) | 349 (305 to 432) | NA |
| Range | 229 to 875 | 229 to 740 | 251 to 875 | NA |
| Mean of CST test–retest on Cirrus, µm | ||||
| Mean (SD) | 365 (113) | 362 (100) | 372 (140) | NA |
| Median (IQR) | 340 (283 to 406) | 346 (290 to 406) | 334 (283 to 398) | NA |
| Range | 176 to 845 | 185 to 723 | 176 to 845 | NA |
| No. of measurement pairs | 374 | 262 | 112 | 150 |
| Difference of CST on Spectralis - Cirrus, µm | ||||
| Mean (SD) | 21 (30) | 21 (27) | 21 (36) | 9 (8) |
| Median (IQR) | 17 (11 to 28) | 17 (11 to 26) | 18 (10 to 32) | 8 (6 to13) |
| Range | −172 to 171 | −84 to 170 | −172 to 171 | −40 to 26 |
NA, Not available. The CADME Study did not have test–retest data.