2 · Matrix, regenerative agents & supportive devices
Human amniotic membrane (graft / PROKERA®)
Review — modulators of corneal healing › 2 · Matrix, regenerative agents & supportive devices › Human amniotic membrane (graft / PROKERA®)
Human amniotic membrane (graft / PROKERA®)
Cryopreserved (AmnioGraft, PROKERA — self-retaining ring) or dehydrated (AmbioDisk) · graft, patch, or filler
Oxford II–IV
Moderate
Present · established
Mechanism of actionCollagen IV/V/VII-, laminin-, and fibronectin-rich basement membrane that serves as a scaffold for epithelial adhesion/migration; anti-inflammatory (exclusion and apoptosis of inflammatory cells, IL-1RA, IL-10), anti-fibrotic (TGF-β suppression), anti-angiogenic, and anti-protease. The HC-HA/PTX3 complex (preserved by cryopreservation, degraded by dehydration) accounts for most of the effect.
IndicationsRefractory neurotrophic PEDs, acute chemical/thermal burns, sterile ulcers and melts, partial limbal deficiency, bullous keratopathy (for pain relief), post-infectious surface reconstruction.
Route & dosageSurgical application (suture or fibrin glue) or self-retaining PROKERA for ~3–5 days (inserted like a large contact lens, sutureless, at the slit lamp). Can be repeated.
Level of evidenceOxford II–IV (a few RCTs, numerous cohorts; Cochrane review with limited certainty for burns) · Scale: Moderate.
| FDA | PROKERA: cleared Class II device (510(k)) — the only cleared ocular amniotic therapeutic device. AmnioGraft/dehydrated grafts = HCT/P tissue (21 CFR 1271 §361). |
|---|---|
| EU MA | Tissue products (Tissues & Cells Directive); national regulation of tissue banks. |
| France | Widely used — supplied by hospital tissue banks (ANSM / Agence de la biomédecine) rather than as a commercial device. PROKERA has limited distribution. |
| USA | PROKERA & grafts widely available. |
| Asia | Widespread use (bank-processed membrane + commercial products; approvals vary). |
Key studies: Lee & Tseng, Am J Ophthalmol 1997 (PED) — PMID 9063239 ; Meller et al., Ophthalmology 2000 (burns) — PMID 10811094 ; Cochrane (Clare, Suleman, Bunce et al. 2012) — PMID 22972141.
See also: Gabison E. “Corneal wound-healing agents”. In: SFO 2023 Report — Médicaments et biothérapies en ophtalmologie, chapter 21. Full text, open access (in French).