Long-term safety after Holoclar® implant for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns: observational study of routine clinical practice (HOLOSIGHT)

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Disease registry

  Spontaneous reports of suspected adverse drug reactions

  Other
• Data sources (types), other:
  Prospective patient-based data collection, Prescription event monitoring, Surgery registry

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No