Table 3.
Baseline Demographic and Ocular Characteristics of Patients with Retinitis Pigmentosa Randomized Patients with Follow-up Visits at All 4 Years (n=225)
| Lutein + vitamin A (12 mg lutein + 15,000 IU vitamin A) (n=110) |
Control + vitamin A (control capsules + 15,000 IU vitamin A) (n=115) |
p-value* | |||
|---|---|---|---|---|---|
| Genetic Type (%) | |||||
| Dominant | 25 (23%) | 28 (24%) | |||
| Recessive | 19 (17%) | 20 (17%) | |||
| X–Linked | 7 (6%) | 8 (7%) | |||
| Isolate | 54 (49%) | 56 (49%) | |||
| Undetermined | 5 (4%) | 3(3%) | 0.95 | ||
| Dietary Intake (Mean±SE) | |||||
| Lutein (mg/day) | 2.50±0.13 | (0.81, 4.58)† | 2.41±0.13 | (0.80, 4.38)† | 0.64 |
| Lutein (mg/day) | 31 (28%) | 38 (33%) | 0.52 | ||
| Blood Values (Mean ± SE)‡ | |||||
| Serum lutein (μg/dL) | 12.1±0.61 | (5.5, 18.1) | 11.7±0.60 | (5.2, 18.7) | 0.69 |
| Serum retinol (μg/dL) | 50.4±1.04 | (38, 66) | 52.1±0.92 | (37, 66) | 0.23 |
| Serum retinyl esters (nmol/L) | 104.3±4.7 | (50, 176) | 112.5±5.30 | (55, 198) | 0.25 |
| Gender, n (%) male | 58 (53%) | 52 (47%) | 0.48 | ||
| Age in years (Mean ± SE) | 40±1.0 | (25, 53) | 38±1.00 | (22, 53) | 0.29 |
| Weight (lbs) | |||||
| Male | 186±4 | (150, 235) | 190±4 | (151, 230) | 0.37 |
| Female | 152±4 | (120, 192) | 150±5 | (117, 199) | 0.75 |
| Baseline Ocular Function§ | |||||
| HFA Total Point Scores (dB) | |||||
| HFA 30-2 Field | 831±47 | (331, 1617) | 858±46 | (316, 1625) | 0.69 |
| HFA 60-4 Field | 360±39 | (41, 877) | 393±33 | (50, 721) | 0.53 |
| HFA 30-2 and 60-4 Combined |
1280±84 | (439, 2303) | 1335±75 | (594, 2290) | 0.63 |
| ERG 30 Hz Amplitude (μV) ¶ | 1.01±0.12 (2.7 4) | (0.81, 13.0) | 1.30±0.11 (3.67) | (0.90, 16.2) | 0.08 |
| ETDRS Visual Acuity (letters) | 50.1±0.9 | (36, 59.5) | 50.3±0.8 | (36, 59) | 0.89 |
| Cataract area OD∥ | 0.59±0.07 | (0, 2.0) | 0.59±0.09 | (0, 2.0) | 0.95 |
| Cataract area OS | 0.51±0.07 | (0, 1.25) | 0.52±0.08 | (0, 2.0) | 0.91 |
p-value for t-test comparing 2 groups for continuous variables: p-value for chi-square for categorical variables.
10th, 90th percentiles for continuous variables.
Normal range for serum retinol = 38-100 μg/dL, for serum retinyl esters = 34-380 nmol/L ; sample sizes for the lutein and control groups respectively were lutein: 110 and 115; serum retinol: 110 and 115; retinyl esters: 110 and 115.
Lower norm for HFA 30-2 field (size V target) = 2500 dB; HFA 60-4 (size V target) = 1580 dB; HFA 30-2 and 60-4 combined field (size V target) = 4200 dB. Lower norm for 30 Hz ERG = 50 μV . Lower norm for ETDRS visual acuity = 60 letters; 51 letters = Snellen acuity of 20/30; sample sizes for lutein and control groups respectively were: HFA 30-2: 110 and 115; HFA 60-4: 90 and 95; HFA 30-2 and 60-4 combined: 88 and 94, 30 Hz ERG : 84 and 87; ETDRS visual acuity: 110 and 115; cataract area: 103 and 110.
Values designated as mean loge±SE. Geometric means for ERG amplitudes in μV in parentheses; 10th, 90th percentiles of ERGs in μV on the raw scale.
Values expressed as percent of total lens area; patients without cataract are included in the analyses with area of zero.