Holosight
Research type
Research Study
Full title
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.
IRAS ID
184635
Contact name
Francisco Figueiredo
Contact email
Sponsor organisation
Holostem S.r.l.
Clinicaltrials.gov Identifier
., ENCePP
Duration of Study in the UK
6 years, 2 months, 0 days
Research summary
Holosight is an observational, non-interventional trial with the primary objective of expanding the body of data so far collected and evaluating the long-term safety profile of patients treated with Holoclar® during a 5-year follow-up period, through the description of the occurrence of adverse events, adverse drug reactions, serious adverse events and adverse events of special interest. Holoclar® is an authorized new treatment indicated for treatment of patients with moderate to severe limbal stem cell deficiency (LSCD) resulting from physical or chemical ocular burns. The treatment of Holoclar® and the associated postsurgical treatment/ assessments will be performed under routine clinical conditions and do not form part of this trial.
The registry will include the first 100 patients treated in the routine clinical practice setting who agree to participate in the registry. Eligible patients receiving Holoclar® will be consecutively included with the first observation being made at the time of corneal biopsy and will be followed for 5 years after the first implant. Follow-up visits are foreseen, according to clinical practice and clinical judgment. Data on the variables collected as part of this routine clinical care will be retrieved from the medical charts available at the centers and Clinical Investigators enrolling patients in this study will record data on the electronic case report forms, which will capture and check the data foreseen in this protocol. Further Patient QoL will be measured by means of EQ-5D and NEI VFQ-25.REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0113
Date of REC Opinion
12 Dec 2017
REC opinion
Further Information Favourable Opinion