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| ID | Type | Description | Link |
|---|---|---|---|
| F35F22000080001 | Other Grant/Funding Number | Ministry of Health |
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The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.
Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.
The study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eye drops derived from cordonal blood serum | Experimental | patients who are given eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| administration cord blood based eye drops, standardized to the deliver BDNF. | Drug | administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal damage measured with National Eye Institute (NEI) score | Evaluation of the effect of cord blood eye drops administration on the variation of corneal damage in patients with severe keratopathy | one week before the start of treatment and thirty days after the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in discomfort | Symptomatology assessment with OSDI questionnaire. Quality of life analysis with Health-related SF-12 questionnaire, and SEI-QoL subjects' quality of life scale. | one week before the start of treatment and thirty days after the end of treatment. |
| Change in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Fontana, MD | Contact | +390512142837 | luigi.fontana6@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Fontana, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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Change in QOL measured by SF-12 questionnaire |
| one week before the start of treatment and thirty days after the end of treatment. |
| Change in quality of life | Change in QOL measured by SEI-QoL questionnaire | one week before the start of treatment and thirty days after the end of treatment. |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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