The THINK Study Incidence of Neurotrophic Keratopathy)

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.

Conditions

Dry Eye

Study Overview

Study Details

Study overview

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.

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

The THINK Study Incidence of Neurotrophic Keratopathy)

Condition
Dry Eye
Intervention / Treatment

-

Contacts and Locations

Laguna Beach

Harvard Eye Associates, Laguna Beach, California, United States, 92653

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Research Insight LLC,

John Hovanesian, MD, PRINCIPAL_INVESTIGATOR, Harvard Eye Associates

Study Record Dates

2025-04-01