Table 1.
Patient demographics and ocular baseline characteristics in the four studies and the integrated dataset
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| Characteristic | MIVI-TRUST*( N = 106) | OASIS ( N = 50) | ORBIT( N = 118) | Integrated( N = 274) |
| Age (years) | ||||
| Mean (SD) | 68.7 (7.4) | 66.5 (6.3) | 66.7 (7.3) | 67.5 (7.2) |
| Median | 69.0 | 65.5 | 66.0 | 67.0 |
| Min, Max | 48, 85 | 49, 79 | 45, 88 | 45, 88 |
| Age group (years), n (%) | ||||
| 65 years | 31 (29.2) | 20 (40.0) | 42 (35.6) | 93 (33.9) |
| 65 years | 75 (70.8) | 30 (60.0) | 76 (64.4) | 181 (66.1) |
| Sex, n (%) | ||||
| Male | 22 (20.8) | 10 (20.0) | 28 (23.7) | 60 (21.9) |
| Female | 84 (79.2) | 40 (80.0) | 90 (76.3) | 214 (78.1) |
| Race, n (%) | ||||
| White | 99 (93.4) | 46 (92.0) | 105 (89.0) | 250 (91.3) |
| Black or African American | 3 (2.8) | 4 (8.0) | 9 (7.6) | 16 (5.8) |
| Asian | 2 (1.9) | 0 (0) | 3 (2.5) | 5 (1.8) |
| Other | 2 (1.9) | 0 (0) | 1 (0.9) | 3 (1.1) |
| Lens status, n (%) | ||||
| Phakic | 81 (76.4) | 43 (86.0) | 93 (78.8) | 217 (79.2) |
| Pseudophakic | 25 (23.6) | 7 (14.0) | 24 (20.3) | 56 (20.4) |
| Aphakic | 0 (0) | 0 (0) | 1 (0.9) | 1 (0.4) |
| ERM status, n (%) | ||||
| Present | 18 (17.0) | 6 (12.0) | 14 (11.9) | 38 (13.9) |
| Absent | 82 (77.3) | 44 (88.0) | 104 (88.1) | 230 (83.9) |
| Missing | 6 (5.7) | 0 (0) | 0 (0) | 6 (2.2) |
| EZ status, n (%) | ||||
| Abnormal | 0 (0) | 49 (98.0) | 116 (98.3) | 165 (60.2) |
| Normal | 0 (0) | 1 (2.0) | 2 (1.7) | 3 (1.1) |
| Missing | 106 (100) | 0 (0) | 0 (0) | 106 (38.7) |
| SRF status, n (%) | ||||
| Present | 77 (72.7) | 49 (98.0) | 0 (0) | 126 (46.0) |
| Absent | 26 (24.5) | 1 (2.0) | 118 (100) | 145 (52.9) |
| Missing | 3 (2.8) | 0 (0) | 0 (0) | 3 (1.1) |
| BCVA (ETDRS letters), n (%) | ||||
| 65 | 89 (84.0) | 37 (74.0) | 96 (81.4) | 222 (81.0) |
| 65–75 | 16 (15.1) | 12 (24.0) | 19 (16.1) | 47 (17.2) |
| 75 | 1 (0.9) | 1 (2.0) | 3 (2.5) | 5 (1.8) |
| FTMH size, n (%) | ||||
| 250 m | 48 (45.3) | 23 (46.0) | 66 (55.9) | 137 (50.0) |
| 250–400 m | 38 (35.9) | 17 (34.0) | 33 (28.0) | 88 (32.1) |
| 400 m | 19 (17.9) | 10 (20.0) | 19 (16.1) | 48 (17.5) |
| Missing | 1 (0.9) | 0 (0) | 0 (0) | 1 (0.4) |
| VMA diameter, n (%) | ||||
| 1500 m | 90 (84.9) | 43 (86.0) | 110 (93.2) | 243 (88.7) |
| 1500 m | 3 (2.8) | 2 (4.0) | 1 (0.9) | 6 (2.2) |
| Missing | 13 (12.3) | 5 (10.0) | 7 (5.9) | 25 (9.1) |
| FTMH width at RPE (m) | ||||
| n | 104 | 50 | 0 | 154 |
| Mean (SD) | 647.1 (283.8) | 634.2 (320.8) | – | 642.9 (295.4) |
| Median | 611.0 | 596.0 | – | 611.0 |
| Min, Max | 113, 1572 | 164, 2120 | – | 113, 2120 |
| FTMH width at RPE, n (%) | ||||
| 600 m | 49 (46.2) | 25 (50.0) | 0 (0) | 74 (27.0) |
| 600 m | 55 (51.9) | 25 (50.0) | 0 (0) | 80 (29.2) |
| Missing | 2 (1.9) | 0 (0) | 118 (100) | 120 (43.8) |
| MIVI-TRUST consisted of two phase 3 clinical trials (NCT00781859 and NCT00798317) BCVA, best-corrected visual acuity; ERM, epiretinal membrane; ETDRS, Early Treatment Diabetic Retinopathy Study; EZ, ellipsoid zone; FTMH, full-thickness macular hole; RPE, retinal pigment epithelium; SD, standard deviation; SRF, subretinal fluid; VMA, vitreomacular traction | ||||