The third cohort included 6 subjects with BCVA
of 20/200 or less, who received a single sub-retinal implantation of OpRegen.
This activity was maintained with an average improvement in BCVA
of 6.5 letters at Day 90 following a single injection of THR-149.
Wilcoxon signed ranked test was used to assess statistical significance of pre and post-operative BCVA
. P<0.05 was considered statistically significant.
Sample size was 73, keeping 95% improvement in BCVA
in post-PPV patients7, at 95% confidence interval and 5% margin of error using WHO sample size calculations.
Gris and his colleagues reported that there was 23.6% increase in the number of patients having BCVA
of 6/9 or better postoperatively11.
The change from pre-treatment to 1-year BCVA
was significantly greater in group 1 than in group 2 (Table 1).
improved from 0.71 +/- 0.19 logMAR and 0.75 +/- 0.11 logMAR before surgery to 0.450 +/- 0.21 logMAR and 0.41 +/- 0.18 logMAR at 6 months after DSEK and DMEK, respectively (Table 2; Fig.
Participants underwent monthly ophthalmic examination for: (a) intraocular pressure (IOP) monitoring via Goldmann Applanation Tonometry, (b) adverse event monitoring, (c) standardised BCVA
assessment in ETDRS letters and (d) colour fundus photography.
The mean values of BCVA
in both eyes were significantly lower in the PDR group (mean value of 0.45) in comparison with the values in patients with NPDR (mean value of 0.84) and WDR group (mean value of 0.83) (Graph 3).
During this visit, the BCVA
was hand movement OD and 20/20 OS.
Patients with bilateral impairment had a mean BCVA
of 0.9 logMAR (range 0-2.30), whereas patients with unilateral disease had a mean BCVA
of 1.02 logMAR (p = 0.54).
(due to objection to occlusion) was 20/63.