Table 4.
Anatomical and functional assessment of patients at 1, 3 and 5 years of follow-up.
| Patients | Corneal Opacity 1 | Central Vascularization 1 | Anatomical Outcome 3 | BCVA 2 | Functional Outcome 4 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-op | 1y | 3y | 5y | Pre-Op | 1y | 3y | 5y | Pre-op | 1y post-Op | Longest FU | |||
| 1 | 3 | 3.5 | 3 | 0 | 1 | 2 | 2 | 0 | F | HM | HM | 6/45 | F |
| 2 | 2 | 0 | 2 | 0 | S | FC 30 cm | 6/24 | 6/9 | S | ||||
| 3a 6 | 0.5 | 0 | 1.5 | 1.5 | 0 | 0 | 0 | 0 | S | HM | 6/45 | 6/45 | S |
| 3b 6 | 1.5 | 0 | ND 5 | 0 | 0 | ND 5 | S | 6/45 | 6/120 | 6/120 | F | ||
| 4 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | S | 6/15 | 6/6 | 6/7.5 | S |
| 5 | 0.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | S | CF 60 cm | 6/18 | 6/24 | S |
| 6 | 0 | 0 | 0 | 0 | 0 | 0 | S | 6/15+1 | 6/45 | 6/60 | F | ||
| 7 | 4 | 2 | 2 | 0 | 4 | 0 | 0 | 0 | S | LP | 6/120 | HM | PS |
| 8 | 0.5 | 0 | 0 | 0.5 | 2 | 0 | 0 | 0 | S | 6/9-2 | 6/18 | 6/9 | F |
| 9 | 2 | 1.5 | 2 | 0 | 2.5 | 0 | 0 | 0 | S | HM | CF 1 m | 6/120 | F |
| 10 | 1 | 0.5 | 0 | 0 | 0 | 0 | S | CF | 6/21 | 6/18 | S | ||
| 11 | 4 | 3.25 | 0 | 0 | 4 | 0 | 0 | 0 | S | LP | LP | LP | F |
| 12 | 2.5 | 1.75 | 0 | 0 | 0 | 0 | 0 | 0 | S | CF | 6/45 | 6/18 | S |
| 13 | 4 | 1 | 2 | 0 | S | CF | 6/60 | 6/60 | S | ||||
| 14 | 1.5 | 0 | 0 | 0 | S | 6/15+2 | 6/45 | 6/12 | F | ||||
| 15 | 2 | 0 | 0 | 0 | 0 | 0 | S | 6/18+2 | 6/30 | 6/30 | F | ||
| Mean Score 7 | 1.9 | 0.7 | 0.7 | 0.1 | 1.2 | 0.1 | 0.2 | 0.0 | |||||
| Mean Score Improvement 8 | 1.2 * | 1.2 * | 1.8 * | 1.1 * | 1.0 | 1.2 * | |||||||
1 For corneal opacity and corneal vascularization a smaller score is better. 2 Functional score was assessed with the Best Corrected Visual Acuity (BCVA). 3 Anatomical outcome 1 year after grafting was assessed as described in Methods. 4 Functional outcome 1 year after grafting was assessed as described in Methods. 5 ND The follow-up was interrupted because of the death of patient 3, which was secondary to a systemic illness unrelated to the research product. 6 This patient required a second graft at five years of follow-up, as LSCD recurred. 3a: Results for the first CACE graft. 3b: Results for the second CACE graft. 7 For the calculation of mean scores, observation 3a was considered at baseline (pre-op), while for post-op results, it was 3b. 8 Mean score improvement = |mean score pre-op-mean score post-op|. * p < 0.05 (bilateral Student T test for paired sample). BCVA-Best corrected visual acuity, F-Failure, FU-Follow-up, y-year(s), CF-Counting fingers, HM-Hand movement, LP-Light perception, cm-Centimeters, m-Meters, PS-Partial success, S-Success.