[HTML][HTML] Five-year follow-up of first 11 patients undergoing injection of cultured corneal endothelial cells for corneal endothelial failure
K Numa, K Imai, M Ueno, K Kitazawa, H Tanaka… - Ophthalmology, 2021 - Elsevier
Ophthalmology, 2021•Elsevier
Purpose To report the safety and efficacy of a novel cell injection therapy using cultured
human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of
the long-term 5-year postoperative clinical data from a first-in-humans clinical trial group.
Design Prospective observational study. Participants This study involved 11 eyes of 11
patients with pseudophakic endothelial failure conditions who underwent hCEC injection
therapy between December 2013 and December 2014. Methods All patients underwent …
human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of
the long-term 5-year postoperative clinical data from a first-in-humans clinical trial group.
Design Prospective observational study. Participants This study involved 11 eyes of 11
patients with pseudophakic endothelial failure conditions who underwent hCEC injection
therapy between December 2013 and December 2014. Methods All patients underwent …
Purpose
To report the safety and efficacy of a novel cell injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term 5-year postoperative clinical data from a first-in-humans clinical trial group.
Design
Prospective observational study.
Participants
This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC injection therapy between December 2013 and December 2014.
Methods
All patients underwent follow-up examinations at 1 week, 4 weeks, 12 weeks, and 24 weeks and 1 year, 2 years, 3 years, 4 years, and 5 years after surgery. Specific corneal endothelial cell parameters (i.e., corneal endothelial cell density [ECD], coefficient of variation of area, and percentage of hexagonal cells) and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure (IOP) were recorded.
Main Outcome Measures
The primary outcome was the change in central ECD after cell injection therapy, and the secondary outcome was corneal thickness, BCVA, and IOP during the 5-year-postoperative follow-up period.
Results
At 5 years after surgery, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean ± standard deviation central corneal ECD was 1257 ± 467 cells/mm2 (range, 601–2067 cells/mm2), BCVA improved significantly in 10 treated eyes, the mean visual acuity changed from 0.876 logarithm of the minimum angle of resolution before surgery to 0.046 logarithm of the minimum angle of resolution after surgery, and no major adverse reactions directly related to the hCEC injection therapy were observed.
Conclusions
The findings in this study confirmed the safety and efficacy of cultured hCEC injection therapy for up to 5 years after surgery.
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