RECRUITING

The THINK Study Incidence of Neurotrophic Keratopathy)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study purpose is to evaluate corneal sensitivity in patients that have Stage 1 Neurotrphic Keratopathy (NK). Identifying patients with Stage 1 NK, may predict those who will in the future require rhNGF for optimal visual performance.

Official Title

The THINK Study (Testing Hypoesthesia and the Incidence of Neurotrophic Keratopathy)

Quick Facts

Study Start:2024-04-05

Study Completion:2025-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06482164

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Able to comprehend and sign a statement of informed consent. * Willing and able to complete all required postoperative visits.	* Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time in the investigator's clinical judgment if it would interfere with the outcome measures of this study. * Evidence of BAK or other chemical toxicity that, in the best judgment of the investigator, is causing reduced corneal sensitivity * Concomitant use of daily contact lenses that, in the best judgment of the investigator, is causing reduced corneal sensitivity * Clinically significant ocular trauma. * Active ocular Herpes simplex or Herpes Zoster infection * Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator. * Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye). * Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings. * Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis. * Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) * Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis). * Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity). * Participation in this trial in the same patient's fellow eye * Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Inclusion Criteria

Exclusion Criteria

* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.

* Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
* Evidence of BAK or other chemical toxicity that, in the best judgment of the investigator, is causing reduced corneal sensitivity
* Concomitant use of daily contact lenses that, in the best judgment of the investigator, is causing reduced corneal sensitivity
* Clinically significant ocular trauma.
* Active ocular Herpes simplex or Herpes Zoster infection
* Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
* Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
* Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
* Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
* Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
* Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
* Participation in this trial in the same patient's fellow eye
* Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

Contacts and Locations

Study Contact

Leslie Lemieux

CONTACT

9513884422

research@researchinsightca.com

Principal Investigator

John Hovanesian, MD

PRINCIPAL_INVESTIGATOR

Harvard Eye Associates

Study Locations (Sites)

Harvard Eye Associates

Laguna Beach, California, 92653

United States

Collaborators and Investigators

Sponsor: Research Insight LLC

John Hovanesian, MD, PRINCIPAL_INVESTIGATOR, Harvard Eye Associates

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-05

Study Completion Date2025-04-01

Study Record Updates

Study Start Date2024-04-05

Study Completion Date2025-04-01

Terms related to this study

Additional Relevant MeSH Terms

Dry Eye