DEFENDO Long Term Follow-up Study in Stage 1 NK Patients

Completed

• Conditions: Neurotrophic Keratitis

• Registration Number: NCT05552261
• Lead Sponsor: Dompé Farmaceutici S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-9-16
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Previously enrolled in the DEFENDO Study.<br><br> 2. Satisfy all Informed Consent requirements. The patient and/or his/her legal<br> representative has read, signed, and dated the IRB approved Informed Consent<br> document before any study-related procedures are performed.<br><br> 3. Must have the ability and willingness to comply with study procedures.<br><br>Exclusion Criteria:<br><br>Participating in another study that involves treating the study eye.<br><br>a. Participation in non-ocular studies is acceptable provided that the treatment is not<br>considered to be confounding with the DEFENDO Long-Term Follow-up Study, in the opinion<br>of the Investigator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal Epithelial Healing;Corneal Epithelial Healing

Secondary Outcome Measures

Name	Time	Method
Corneal Sensitivity;Change from Baseline in BCDVA at 24 months and 30 months;Change from Baseline in TFBUT at 24 months and 30 months;Percentage of patients that achieve a 15- letter gain in BCDVA;Change from baseline in Quality of life (QoL) change from baseline;Change from baseline in Quality of life (QoL) change from baseline;Change from baseline in corneal nerve structure (IVCM) at months 24 and 30;Change from baseline in Optical Coherence Tomography (OCT) at months 24 and 30