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Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns

NCT03288844 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2023-05-26

No results posted yet for this study

Summary

This is a multinational, multicentre, prospective, non-pharmacological follow-up study of the clinical trial HOLOCORE. All patients transplanted with Holoclar in the HOLOCORE clinical trial who consent to participate will be enrolled in this prospective study and observed for at least 12 months.

Conditions

  • Limbal Stem Cell Deficiency Due to Ocular Burn

Interventions

PROCEDURE

Ophthalmologic examinations

epithelial defects assessment by fluorescein staining; superficial corneal neo-vascularization assessment; ocular tonometry; slit lamp examination; conjunctival (both bulbar and limbal) inflammation assessment; corneal sensitivity; central cornea involvement (for opacity or central CNV); Best-Corrected Visual Acuity; evaluation of symptoms.

OTHER

Digital pictures

Digital pictures 2D to be taken at each visit

OTHER

QoL Questionnaires

Quality of Life (NEI VFQ 25 and EQ-5D-3L/Y) questionnaires will be submitted at each visit

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • Holostem s.r.l.

    lead INDUSTRY

Principal Investigators

  • Graziella Pellegrini, Professor · Holostem s.r.l.

  • Paolo Rama, MD · Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288844 on ClinicalTrials.gov