The THINK Study Incidence of Neurotrophic Keratopathy) (NCT06482164) | Clinical Trial Compass
CompletedNot Applicable
The THINK Study Incidence of Neurotrophic Keratopathy)
United States31 participantsStarted 2024-04-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
\*Patients with the following: A diagnosis of dry eye disease Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.
* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.
Exclusion Criteria:
* 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 gia…
What they're measuring
1
Patients with stage 1 neurotrophic keratopathy (NK)