International Corneal Neurotization Registry
G
Gregory Borschel, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
100 participants needed
1 Location
Brief description of study
The aim of this study is to develop an international Registry capturing important patient, surgical, and outcome data on corneal neurotization procedures, especially patients undergoing corneal neurotization surgery to treat Neurotrophic Keratopathy.
Detailed description of study
Participants in this study will be undergoing corneal neurotization as part of their care.
During this study we will collect the following information:
• Source of baseline enrolment (nationality/institution)
• Date of birth and gender.
• Medical and surgical history, including diagnosis of Neurotrophic Keratopathy (NK), cause(s) of NK, previous NK treatment/procedure, and other conditions.
• Assessment results of the affected eye(s) including classification of NK, and assessments of corneal sensitivity, visual acuity, and dry eye.
The corneal neurotization surgery will be the same (standard-of-care) as people not participating in this study. Participants will have research data recorded during the surgical procedure, including:
• Source of donor nerve.
• Source and technique of nerve graft (if applicable).
• Method and placement of nerve attachment (coaptation).
After surgery, participants will be asked to complete normal standard of care visits. During these standard of care visits, additional research data will be recorded:
• Classification of NK.
• Occurrence of damage to the cornea (persistent epithelia defect).
• Cornea damage (if any).
• Corneal sensitivity.
• Visual acuity.
• Dry eye.
• Your usage of topical agents and contact lens will also be recorded.
At all visits, participants and/or parents/guardians will be asked to complete a survey to measure physical, mental, and social health.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: corneal neurotization, neurotrophic keratopathy
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Consent provided by participant and/or legally authorized representative
- Must have NK that is treatable with corneal neurotization surgery
Exclusion Criteria:
- Patients who have no available appropriate donor nerve
- Patients with significant immunosuppression or poor systemic health
- Patients with severe conjunctival scarring
- Patients with active ocular or periocular inflammatory, neoplastic, or infectious conditions.
Updated on
01 Aug 2024.
Study ID: 13236, SURG-IIR-ICN-REGISTRY
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