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Quantitative Sensory Testing for Corneal Nerve Function
N/A
Waitlist Available
Led By Pedram Hamrah, MD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from visit 1 up to 4 weeks
Awards & highlights
Study Summary
This trial studies the effects of heat, cold, and vibration on eye pain during a routine eye exam. #QST #MedicalResearch
Who is the study for?
This trial is for people with early-stage Neurotrophic Keratopathy (NK), Dry Eye Disease (DED) symptoms for at least 3 months, or neuropathic corneal pain (NCP). Healthy individuals can also join. It's not for those with major psychiatric illnesses, recent surgeries, certain diseases like sarcoidosis, allergies to BAK in eye drops, non-English speakers, diabetics, or anyone on anti-inflammatory/steroid treatments recently.Check my eligibility
What is being tested?
The study tests how heat, cold and vibration stimuli affect ocular pain response using Quantitative Sensory Testing (QST). Except QST, all other procedures are routine eye exams. Participants include those with NK stages I & II, DED sufferers and healthy volunteers.See study design
What are the potential side effects?
Since most of the procedures are standard eye examinations and the main intervention is a sensory test that does not involve medication or surgery there may be minimal side effects such as temporary discomfort from the testing stimuli.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from visit 1 up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit 1 up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differences in mechanical stimulus pain threshold across the 4 study arms
Differences in thermal stimulus pain threshold across the 4 study arms
Mechanical stimulus response to QST on site of trigeminal nerve first branch, as assessed by vibration detection threshold (VDT)
+1 moreSecondary outcome measures
To compare QST response differences between trigeminal nerve first branch and forearm in patients.
To correlate symptom severity as assessed by the Ocular Surface Disease Index (OSDI), to stimulus response across the 4 interventional arms.
To correlate the QST responses with morphological changes of corneal nerves detected by IVCM
Trial Design
4Treatment groups
Experimental Treatment
Group I: Stage II Neurotrophic KeratopathyExperimental Treatment1 Intervention
Clinical findings of corneal epithelial defect with smooth and rolled edges, decreased nerve density as assessed by in vivo confocal microscopy (IVCM), and decreased corneal sensation.
Group II: Stage I Neurotrophic KeratopathyExperimental Treatment1 Intervention
Clinical findings of corneal hyperplasia and irregularity, scattered small facets of dried epithelium, decreased nerve density as assessed by in vivo confocal microscopy (IVCM), and decreased corneal sensation.
Group III: Healthy IndividualsExperimental Treatment1 Intervention
Absence of any ocular symptoms, absence of surface findings (including corneal or conjunctival staining, corneal scar or surgical wound), and normal corneal sensation.
Group IV: Dry Eye DiseaseExperimental Treatment1 Intervention
Symptoms of dry eye disease for at least 3 months, supported by clinical finding of decreased tear film break-up time or ocular surface staining. Normal corneal sensation.
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Who is running the clinical trial?
Dompé Farmaceutici S.p.AIndustry Sponsor
49 Previous Clinical Trials
4,426 Total Patients Enrolled
1 Trials studying Corneal Diseases
Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
255,629 Total Patients Enrolled
2 Trials studying Corneal Diseases
438 Patients Enrolled for Corneal Diseases
Pedram Hamrah, MDPrincipal InvestigatorTufts Medical Center
10 Previous Clinical Trials
1,746 Total Patients Enrolled
2 Trials studying Corneal Diseases
438 Patients Enrolled for Corneal Diseases
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Stage II NK with symptoms like less nerve density and reduced corneal sensation.I have not had eye surgery, eye infections, or eye injuries in the last 3 months.I have a history of diabetes.I have not taken steroids or immune therapy in the last 3 months.I am healthy with no eye surface symptoms, clear cornea, and normal feeling in my cornea.I have had surgery within the last 3 months.I experience nerve pain that doesn't match my physical exams, confirmed by a special microscope test.I have had dry eye symptoms for over 3 months and have at least one sign of DED.I have early-stage Neurotrophic Keratopathy with less nerve density and feeling in my cornea.I have a history of sarcoidosis, GVHD, or a collagen vascular disease.
Research Study Groups:
This trial has the following groups:- Group 1: Stage I Neurotrophic Keratopathy
- Group 2: Stage II Neurotrophic Keratopathy
- Group 3: Dry Eye Disease
- Group 4: Healthy Individuals
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are opportunities to participate in this trial currently available?
"As displayed on clinicaltrials.gov, this medical trial is not presently recruiting participants. The study was initially listed on May 16th 2023 and edited as recently as June 11th 23rd - however there are currently 184 other trials that are actively enrolling patients."
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