Table 1. Baseline Characteristics by Baseline Nonperfusion on UWF-FA.
| Characteristic | Nonperfusion, No. (%) | |||
|---|---|---|---|---|
| No | Low | Medium | High | |
| No. of eyes | 47 | 153 | 154 | 154 |
| Participant characteristics | ||||
| Female | 23 (49) | 62 (41) | 85 (55) | 82 (53) |
| Male | 24 (51) | 91 (59) | 69 (45) | 72 (47) |
| Age, median (IQR), y | 63 (46-68) | 60 (51-67) | 60 (50-68) | 63 (53-69) |
| Race and ethnicitya | ||||
| White | 34 (72) | 91 (59) | 111 (72) | 111 (72) |
| Black or African American | 7 (15) | 32 (21) | 25 (16) | 24 (16) |
| Hispanic or Latino | 2 (4) | 20 (13) | 13 (8) | 12 (8) |
| Asian | 3 (6) | 3 (2) | 1 (<1) | 6 (4) |
| More than 1 race | 0 | 3 (2) | 2 (1) | 1 (<1) |
| Native Hawaiian, Other Pacific Islander | 0 | 1 (<1) | 0 | 0 |
| Unknown or not reported | 1 (2) | 3 (2) | 2 (1) | 0 |
| Diabetes type | ||||
| Type 1 | 8 (17) | 13 (8) | 30 (19) | 27 (18) |
| Type 2 | 39 (83) | 136 (89) | 124 (81) | 125 (81) |
| Uncertain | 0 | 4 (3) | 0 | 2 (1) |
| Duration of diabetes, median (IQR) | 21 (14-28) | 17 (13-25) | 19 (12-28) | 23 (16-29) |
| Hemoglobin A1c, median (IQR), %b | 7.8 (6.8-8.7) | 8.4 (7.3-9.7) | 8.1 (7.0-9.5) | 7.6 (7.0-8.8) |
| Insulin use | 34 (72) | 110 (72) | 114 (74) | 119 (77) |
| Mean arterial pressure, median (IQR), mm Hg | 98 (93-108) | 99 (93-110) | 96 (90-105) | 96 (88-104) |
| History of hypertension | 38 (81) | 118 (77) | 118 (77) | 120 (78) |
| History of high cholesterol/dyslipidemia | 39 (83) | 104 (68) | 102 (66) | 99 (64) |
| Taking fenofibrate at baseline | 1 (2) | 4 (3) | 10 (6) | 4 (3) |
| Taking metformin at baselinec | 27 (60) | 70 (47) | 73 (50) | 61 (41) |
| eGFR, median (IQR), mL/min/1.73 m2d | 90 (67-90) | 87 (61-90) | 90 (67-90) | 84 (63-90) |
| Participants with eGFR <60 mL/min/1.73 m2 | 6 (13) | 19 (12) | 14 (9) | 20 (13) |
| Participants with eGFR ≥60 mL/min/1.73 m2 | 26 (55) | 70 (46) | 65 (42) | 69 (45) |
| Unknown eGFR | 15 (32) | 64 (42) | 75 (49) | 65 (42) |
| Albumin to creatinine ratiod | ||||
| Median (IQR) | 8 (4-94) | 53 (12-173) | 17 (5-63) | 20 (8-63) |
| No albuminuria (<30) | 20 (43) | 40 (26) | 50 (32) | 54 (35) |
| Microalbuminuria (30-300) | 8 (17) | 32 (21) | 21 (14) | 21 (14) |
| Macroalbuminuria (>300) | 4 (9) | 17 (11) | 7 (5) | 11 (7) |
| Unknown | 15 (32) | 64 (42) | 76 (49) | 68 (44) |
| Participants with 2 study eyes | 32 (68) | 111 (73) | 109 (71) | 86 (56) |
| Study eye ocular characteristics | ||||
| Visual acuity letter score, median (IQR) | 85 (90-80) | 86 (90-82) | 86 (90-82) | 85 (89-80) |
| Snellen equivalent, median (IQR) | 20/20 (20/16-20/25) | 20/20 (20/16-20/25) | 20/20 (20/16-20/25) | 20/20 (20/16-20/25) |
| DRSS score by reading center assessment (UWF masked color image) | ||||
| Mild NPDR (35) | 30 (64) | 51 (33) | 41 (27) | 34 (22) |
| Moderate NPDR (43) | 11 (23) | 40 (26) | 42 (27) | 47 (31) |
| Moderately severe NPDR (47) | 3 (6) | 30 (20) | 24 (16) | 19 (12) |
| Severe and very severe NPDR (53) | 3 (6) | 32 (21) | 47 (31) | 54 (35) |
| DRSS score by reading center assessment (UWF unmasked color image) | ||||
| Mild NPDR (35) | 26 (55) | 40 (26) | 33 (21) | 26 (17) |
| Moderate NPDR (43) | 14 (30) | 42 (27) | 36 (23) | 33 (21) |
| Moderately severe NPDR (47) | 3 (6) | 36 (24) | 29 (19) | 30 (19) |
| Severe and very severe NPDR (53) | 4 (9) | 33 (22) | 54 (35) | 57 (37) |
| Inactive PDR (60) or mild PDR (61) | 0 | 1 (<1) | 2 (1) | 3 (2) |
| Moderate PDR (65) | 0 | 0 | 0 | 5 (3) |
| Ungradable | 0 | 1 (<1) | 0 | 0 |
| Difference in DRSS score by reading center assessment (UWF unmasked vs masked color image)e | ||||
| UWF unmasked worse | 5 (11) | 16 (11) | 24 (16) | 36 (23) |
| Same grading | 42 (89) | 133 (88) | 128 (83) | 116 (75) |
| UWF masked worse | 0 | 3 (2) | 2 (1) | 2 (1) |
| Lens status | ||||
| Aphakic | 0 | 0 | 0 | 1 (<1) |
| PC IOL | 4 (9) | 22 (14) | 41 (27) | 55 (36) |
| Phakic | 43 (91) | 131 (86) | 113 (73) | 98 (64) |
| OCT CST Spectralis equivalent, median (IQR), μmf | 282 (258-294) | 274 (260-290) | 278 (258-294) | 281 (263-298) |
| OCT volume, median (IQR), mm2g | 6.9 (6.6-7.2) | 7.0 (6.6-7.3) | 7.0 (6.7-7.3) | 6.9 (6.6-7.4) |
| History of DME treatment | 3 (6) | 28 (18) | 46 (30) | 32 (21) |
| Focal laser for DME | 3 (6) | 27 (18) | 44 (29) | 31 (20) |
| Anti-VEGF for DME | 1 (2) | 10 (7) | 10 (6) | 6 (4) |
| Corticosteroids (including implants) for DME | 0 | 1 (<1) | 3 (2) | 1 (<1) |
| Presence of predominantly peripheral lesions on UWF-FA | 17 (36) | 42 (27) | 85 (55) | 84 (55) |
Abbreviations: CST, central subfield thickness; DME, diabetic macular edema; DR, diabetic retinopathy; DRSS, Diabetic Retinopathy Severity Scale; eGFR, estimated glomerular filtration rate; FA, fluorescein angiography; NPDR, nonproliferative diabetic retinopathy; OCT, optical coherence tomography; PC IOL, posterior chamber intraocular lens; PDR, proliferative diabetic retinopathy; UWF, ultra-widefield; VEGF, vascular endothelial growth factor.
Participant-reported race and ethnicity were collected based on fixed categories.
Unavailable for 1 eye in the no-nonperfusion, 3 in low-nonperfusion, 2 in medium-nonperfusion, and 1 in high-nonperfusion subgroups.
Unavailable for 2 eyes in the no-nonperfusion, 4 in low-nonperfusion, 8 in medium-nonperfusion, and 4 in high-nonperfusion subgroups. Percentage is based on eyes with available information.
Blood and urine samples were implemented about 5 months after study recruitment began.
Excludes 1 eye with ungradable unmasked DR grades. Percentage is based on eye with gradable DR severity on both images.
Cirrus measurements were converted to Spectralis equivalents using the following formula: Spectralis = 40.78 + 0.95 × Cirrus.
Retinal volume measurements were converted to Stratus equivalents using the following formulae: Stratus = −1.21 + 1.02 × Cirrus; Stratus = −2.05 + 1.06 × Spectralis.