Table 2.
Baseline Participant and Ocular Characteristics
| N=293 | |
|---|---|
| Participant-level | |
|
| |
| Age (years)-Mean±standard deviation (Min, Median, Max) | 65±9 (29, 65, 85) |
| Gender | |
| Women | 171 (58%) |
| Race/Ethnicity | |
| White | 191 (65%) |
| Black | 67 (23%) |
| Hispanic | 26 (9 %) |
| Asian | 2 (1%) |
| Native Hawaiian/ Pacific Islander | 3 (1%) |
| Unknown/not reported | 4 (1%) |
| Diabetes Type | |
| Type 1 | 34 (12%) |
| Type 2 | 242 (83%) |
| Uncertain | 17 (6%) |
| Duration of Diabetes- (Years); Mean±STD | 21±12 |
| HbA1c*-(%); Mean±STD | 7.7±1.5 |
|
| |
| Ocular-level | |
|
| |
| Visual Acuity | |
| Letter Score-Mean±STD (Median) | 66±15 (69) |
| Snellen Equivalent-Mean (Median) | 20/50 (20/40) |
| ≥ 69 (20/40 or better)-N (%) | 151 (52%) |
| 68-54 (20/50 to 20/80)-N (%) | 97 (33%) |
| 53-39 (20/100 to 20/160)-N (%) | 26 (9%) |
| ≤38 (20/300 or worse) N (%) | 19 (6%) |
| Diabetic Retinopathy¶-N (%) | |
| Microaneurysms only | 63 (22%) |
| Mild/moderate NPDR | 131 (45%) |
| Severe NPDR | 15 (5%) |
| PDR and/or prior scatter | 84 (29%) |
| Prior History of PRP | 71 (24%) |
| History of DME Treatment-n (%) | 128 (44%) |
| History of Recent Injection for DME ** | 29 (10%) |
| Baseline DME Subgroup † | |
| A. No central-involved DME & No non-central involved DME |
17 (6%) |
| B. No central-involved DME & Definite/possible if non- central involved DME |
100 (36%) |
| C. Possible if central-involved DME and No non- central involved DME |
5 (2%) |
| D. Possible if central involved DME and Definite/possible if non central involved DME |
153 (56%) |
| OCT- Mean ±STD (Min, Max) | |
| Time Domain | |
| CSF Thickness μm (N = 281) | 201±26 (114, 249) |
| Retinal Volume mm3 §(N = 261) | 6.7± 0.6 (4.3, 8.8) |
| Spectral Domain | |
| CSF Thickness μm (N = 12) | 244±32 (178, 284) |
| Retinal Volume mm3 §(N = 9) | 8.97±1.29 (6.96, 10.20) |
| OCT Machines | |
| Zeiss Stratus | 281 (96%) |
| Zeiss Cirrus | 8 (3%) |
| Optovue RTVue | 2 (1%) |
| Heidelberg Spectralis | 2 (1%) |
HbA1c=hemoglobin A1c; NPDR=non-proliferative diabetic retinopathy; PDR=proliferative diabetic retinopathy; PRP=panretinal photocoagulation; DME=diabetic macular edema; OCT=optical coherence tomography; CSF=central subfield;
Missing in 13 participants
By clinical exam. Scale: None, Microaneurysms only, Mild/moderate NPDR, Severe NPDR and PDR
Intravitreal or peribulbar corticosteroids within the last 4 months prior to surgery or on the day of surgery; anti-VEGF therapy within the last 2 months prior to surgery or on the day of surgery
Missing in 18 (6%); 5 eyes, originally classified in the possible central-involved DME and no non-central involved DME group, were individually examined by the protocol chair due to small numbers in the subgroup and were reclassified into the no central or non-central involved DME (N = 1), no central-involved DME and definite/possible non-central involved DME (N = 1) and the possible central-involved and definite/possible non-central involved DME (N = 3) groups respectively in the analysis.
Missing 20 in time domain and 3 spectral domain: non-gradable by the reading central