Table III.
PRE/POST-BED REST EQUIVALENCY TESTS.
| Outcome | Clinical Threshold for Equivalence | Observed Mean Pre/Post Delta | Optimal Alpha 95% CI | |
|---|---|---|---|---|
| Lower Bound | Upper Bound | |||
| Best-Corrected Visual Acuity, logMAR | ||||
| Distance | 0.10 | −0.01 | −0.05 | 0.03 |
| Near | 0.10 | −0.06 | −0.10 | −0.02 |
|
| ||||
| Spherical Equivalent, D | ||||
| Retinomax K-plus 3 | 0.50 | −0.30 | −0.56 | −0.04 |
| Reichert RK 600 | 0.50 | −0.16 | −0.36 | 0.03 |
|
| ||||
| Intraocular pressure, mmHg | ||||
| iCare | 2.00 | −0.43 | −1.69 | 0.83 |
| Tonopen AVIA | 4.00 | −2.50 | N/A | N/A |
| Tonopen XL | 4.00 | 3.03 | −5.24 | 11.31 |
| Goldmann | 2.00 | −0.32 | −0.97 | 0.33 |
|
| ||||
| Cirrus HD-OCT | ||||
| Optic Disc Cube 200×200 Protocol | ||||
| Average RNFLT, μm | 4.00 | 0.43 | −0.69 | 1.69 |
| Rim Area, mm2 | 3.26 | 0.01 | −0.11 | 0.12 |
| Disc Area, mm2 | 3.93 | −0.01 | −0.12 | 0.11 |
| Average Cup/Disc | 0.67 | −0.01 | −0.05 | 0.03 |
| Vertical Cup/Disc | 1.41 | −0.02 | −0.06 | 0.03 |
| Cup Volume, mm3 | 0.38 | −0.00 | −0.02 | 0.01 |
| Quadrants RNFLT, μm | ||||
| Temporal | 4.00 | 1.04 | −0.02 | 2.11 |
| Superior | 10.00 | 0.61 | −2.78 | 4.03 |
| Nasal | 8.00 | −0.14 | −1.90 | 2.03 |
| Inferior | 9.00 | 0.18 | −1.49 | 2.03 |
| Clock-hours RNFLT, μm | ||||
| 1 | 15.00 | 0.80 | −3.00 | 4.80 |
| 2 | 14.00 | −0.80 | −3.63 | 2.22 |
| 3 | 8.00 | −0.49 | −2.87 | 1.96 |
| 4 | 10.00 | 0.51 | −1.44 | 3.35 |
| 5 | 14.00 | 1.06 | −1.88 | 4.88 |
| 6 | 17.00 | −1.55 | −4.52 | 2.07 |
| 7 | 15.00 | 0.86 | −3.31 | 4.10 |
| 8 | 10.00 | 0.84 | −1.45 | 2.91 |
| 9 | 4.00 | 0.96 | −0.14 | 2.14 |
| 10 | 7.00 | 1.18 | −0.75 | 3.21 |
| 11 | 14.00 | 1.33 | −2.91 | 5.28 |
| 12 | 17.00 | −0.18 | −5.61 | 5.32 |
| Macular Cube 512×128 Protocol | ||||
| Central Subfield Thickness, μm | 8.04 | −0.71 | −3.52 | 2.06 |
| Macular Cube Volume, mm3 | 0.10 | 0.03 | 0.00 | 0.07 |
| Macular Cube Average Thickness, μm | 1.70 | 0.86 | 0.19 | 1.61 |
| ILM/RPE Thickness, μm | ||||
| Temporal Outer | 8.15 | 0.88 | −1.50 | 3.38 |
| Temporal Inner | 9.71 | 0.20 | −3.14 | 3.55 |
| Superior Outer | 8.65 | 1.16 | −1.26 | 3.64 |
| Superior Inner | 10.09 | −0.04 | −2.86 | 2.86 |
| Nasal Outer | 9.21 | 1.12 | −1.04 | 3.33 |
| Nasal Inner | 10.15 | −0.86 | −4.09 | 2.25 |
| Inferior Outer | 8.39 | 1.02 | −1.75 | 3.75 |
| Inferior Inner | 10.00 | 0.33 | −3.20 | 3.83 |
| Central | 8.04 | −0.71 | −3.52 | 2.06 |
|
| ||||
| Spectralis OCT | ||||
| Macular Thickness,* μm | ||||
| Temporal | 8.43 | −0.10 | −2.77 | 2.57 |
| Superior | 8.73 | 0.34 | −2.53 | 3.21 |
| Nasal | 8.78 | 0.26 | −2.64 | 3.16 |
| Inferior | 8.67 | 0.38 | −1.69 | 2.45 |
| Central | 7.00 | −1.66 | −3.80 | 0.48 |
| Average | 8.32 | −0.16 | −2.86 | 2.55 |
| Macular Volume,* mm3 | ||||
| Temporal | 0.01 | −0.00 | −0.01 | 0.01 |
| Superior | 0.01 | 0.00 | 0.00 | 0.01 |
| Nasal | 0.01 | 0.00 | 0.00 | 0.01 |
| Inferior | 0.01 | 0.00 | 0.00 | 0.00 |
| Central | 0.01 | −0.00 | 0.00 | 0.00 |
| Average | 0.01 | 0.00 | 0.00 | 0.00 |
| Peripapillary Retinal Thickness,* μm | ||||
| Temporal | 15.22 | 3.50 | −0.89 | 7.89 |
| Superior | 19.35 | 5.30 | 0.24 | 10.36 |
| Nasal | 17.82 | 4.64 | 0.04 | 9.25 |
| Inferior | 19.85 | 5.60 | −1.07 | 12.27 |
| Central | 15.49 | 3.33 | −2.68 | 8.60 |
| Average | 17.54 | 4.51 | −1.00 | 10.01 |
| Peripapillary Retinal Volume,* mm3 | ||||
| Temporal | 0.02 | 0.01 | 0.00 | 0.01 |
| Superior | 0.03 | 0.01 | 0.00 | 0.02 |
| Nasal | 0.03 | 0.01 | 0.00 | 0.01 |
| Inferior | 0.03 | 0.01 | 0.00 | 0.02 |
| Central | 0.01 | 0.00 | 0.00 | 0.01 |
| Average | 0.03 | 0.01 | 0.00 | 0.02 |
| Scan Circle Protocol | ||||
| Temporal RNFLT, μm | 1.42 | 0.48 | −0.09 | 1.05 |
| Temporal Superior RNFLT, μm | 2.21 | 0.40 | −0.35 | 1.15 |
| Nasal Superior RNFLT, μm | 2.12 | 0.52 | −0.11 | 1.15 |
| Nasal RNFLT, μm | 1.76 | 0.90 | 0.04 | 1.76 |
| Nasal Inferior RNFLT, μm | 2.16 | 3.48 | 2.20 | 4.76 |
| Temporal Inferior RNFLT, μm | 2.28 | 1.58 | 0.78 | 2.38 |
| Average RNFLT, μm | 1.19 | 1.14 | 0.69 | 1.59 |
CI, confidence interval; ILM/RPE, internal limiting membrane/retinal pigment epithelium; MAR, minimum angle of resolution; N/A, not applicable; RNFLT, retinal nerve fiber layer thickness.
*
Inner and central sectors of the Early Treatment Diabetic Retinopathy Study grid
Bold, exceeded clinical threshold. Non-equivalence determined by two one-sided t-tests failing to reject the null hypothesis that the pre/post-bed rest differences are within the clinical threshold for equivalence.