Table 1.
24-month clinical safety and efficacy measures of BPCDX implantation in advanced keratoconus patients in two pilot clinical case series
| Iranian cohort | Pre-operative | 24 months | P value1 |
|---|---|---|---|
| Number of subjects | 12 | 12 | |
| Subject Age (years) | 30.8 ± 9.7 | ||
| Age range (years) | 18–43 | ||
| Number of females/males | 5/7 | ||
| Number of 280/440 µm BPCDX | 5/7 | ||
| Corneal transparency | Good (4+) | Good (4+) | |
| Central corneal thickness (µm) | 446 ± 66 | 728 ± 88 | 2.4 × 10−6 |
| Thinnest point (µm) | 405 ± 69 | 683 ± 88 | 1.8 × 10−5 |
| Corneal volume (mm3) | 57.1 ± 3.0 | 75.2 ± 7.4 | 2.0 × 10−5 |
| Mean keratometry Km (D) | 57.7 ± 6.5 | 52.8 ± 1.9 | 0.013 |
| Max keratometry Kmax (D) | 69.1 ± 9.0 | 58.8 ± 4.0 | 0.002 |
| BSCVA (logMAR) | 1.22 ± 0.54 | 0.46 ± 0.22 | 2.5 × 10−4 |
| logMAR lines gained, BSCVA | 7.6 ± 6.1 | ||
| Contact lens tolerant subjects | 0/12 | 12/12 | |
| Legally blind subjects2 | 6 | 0 | |
| Indian Cohort | Pre-operative | 24 months | P value1 |
| Number of subjects | 8 | 8 | |
| Subject Age (years) | 26.6 ± 4.7 | ||
| Age range (years) | 19–31 | ||
| Number of females/males | 2/6 | ||
| Number of 280/440 µm BPCDX | 8/0 | ||
| Corneal transparency | Good (4+) | Good (4+) | |
| Central corneal thickness (µm) | 378 ± 15 | 587 ± 18 | 7.0 × 10−9 |
| Mean keratometry Km (D) | 57.1 ± 7.0 | 48.4 ± 1.5 | 0.011 |
| Max keratometry Kmax (D) | 62.7 ± 7.5 | 48.8 ± 1.3 | 0.002 |
| BCLVA (logMAR) | 1.63 ± 0.15 | 0.12 ± 0.11 | 1.2 × 10−7 |
| logMAR lines gained, BCLVA | 15.1 ± 2.0 | ||
| Intraocular pressure (mmHg) | 11.8 ± 0.7 | 13.5 ± 1.5 | 0.009 |
| Contact lens tolerant subjects | 0/8 | 8/8 | |
| Legally blind subjects2 | 8 | 0 |
1Final follow-up relative to pre-operative, two-tailed paired t-test.
2Legally blind if logMAR BCVA ≥ 1.30 and contact lens intolerant.