Compared with sutured amniotic membrane transplantation (AMT), patients who received a ProKera® (Bio-Tissue) device were associated with decreased healing time and health care costs, according to results of a retrospective case series, published in Cornea.
Researchers reviewed patient (N=28) records from the Centre hospitalier de l’Université de Montréal collected between 2015 and 2020. All eyes received either a 16 mm ProKera device (n=16, median age 53.0 years) or sutured AMT (n=14, median age 69.9 years.). Implants were removed when they no longer sufficiently covered the corneal defect. The patients were assessed for ocular surface healing, symptoms, visual acuity, light perception, and health care utilization.
The most common indications for treatment were chemical burn (6 vs 2), post-penetrating keratoplasty neurotropic ulcer (5 vs 4), and other neurotrophic ulcers (3 vs 6), respectively.
After the procedure, 64.2% of the ProKera and 71.4% of the AMT cohorts had better visual acuity compared with baseline.
The ProKera recipients had a shorter time to dissolution or removal (mean, 24.8 vs 50.1 days; P =.023) and higher percentage healed per day (mean, 4.3% vs 0.9% per day; P =.035) but with a smaller total area healed, with 59±14% of the corneal surface area healed in the ProKera group vs 73±19% of the AMT group (P =.003). The percentage of healed corneal surface area was defined as (final area – initial area)/initial area x 100%. The researchers approximated epithelial defects as rectangular areas and measured the height and width. The final area indicates the size of the corneal defect at the time of removing or dissolution of ProKera or AM.
After device dissolution or removal, some patients in both the ProKera and AMT cohorts required penetrating keratoplasty (2 vs 5), tarsorrhaphy (2 vs 3), or bandage contact lens (2 vs 2) procedures, respectively.
Although the cost of the ProKera device itself was more expensive than AMT ($699 vs $275.00), the additional costs of surgeon compensation ($238.15), sutures ($18.90), operation room costs ($51.24 per min; ~20 min operation time), and bandage contact lens ($467) associated with the AMT procedure made ProKera a more economically feasible treatment ($699 vs $1561.52).
To assess whether the decreased health care costs of ProKera were worth the decreased total area healed, the study investigators calculated the average treatment cost per area healed. They found that ProKera was still the most cost-effective treatment at $11.85 per 1% area compared with $21.39 per 1% for AMT.
This study was limited as the cost analysis was based on the Canadian system and may not be generalizable.
These data indicated that patients who received a ProKera device for a corneal defect were associated with decreased health care utilization and healing time.
Zhou TE, Robert MC. Comparing ProKera with amniotic membrane transplantation: indications, outcomes, and costs. Cornea. Published online September 4, 2021. doi:10.1097/ICO.0000000000002852