Prospective Study to Validate the Imaging Biomarker for NCP (R33)
NCT ID: NCT05653921
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
438 participants
OBSERVATIONAL
2022-12-16
2026-10-31
Brief Summary
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Detailed Description
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Neuropathic corneal pain (NCP), an ocular and severe type of neuropathic pain describes patients with symptoms of ocular discomfort out of proportion with clinical signs. The lack of clinical signs observed by standard ophthalmic examination has resulted in underdiagnosis of NCP or misdiagnosis as dry eye disease. Thus, having a biomarker for NCP is critical to identify and treat these patients. No biomarker or clinical signs exists to identify NCP patients.
Investigating corneal neurosensory abnormalities could help to diagnose NCP and potentially differentiate these patients from those with DED. In vivo confocal microscopy (IVCM) allows for real-time optical biopsies at a quasi-histological level, allowing for assessment of corneal nerves. IVCM non-invasive diagnostic imaging across NCP, DED, and healthy individuals will be analyzed to validate corneal microneuromas as a biomarker for NCP.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dry Eye Disease Group
Symptoms of ocular surface discomfort or dry eye disease for at least 3 months, supported by clinical exam findings. Reported quality of life is not effected by ocular pain.
In vivo confocal microscopy (IVCM)
In vivo confocal microscopy (IVCM) allows for visualization of the corneal structures at the cellular level, allowing for assessment of corneal nerves. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Neuropathic Corneal Pain Group
Symptoms of ocular surface discomfort or pain for at least 3 months, that are reported to have a significant impact on quality of life and ability to perform daily activities.
In vivo confocal microscopy (IVCM)
In vivo confocal microscopy (IVCM) allows for visualization of the corneal structures at the cellular level, allowing for assessment of corneal nerves. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Control Group
No symptoms of ocular surface discomfort or dry eye disease.
In vivo confocal microscopy (IVCM)
In vivo confocal microscopy (IVCM) allows for visualization of the corneal structures at the cellular level, allowing for assessment of corneal nerves. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Interventions
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In vivo confocal microscopy (IVCM)
In vivo confocal microscopy (IVCM) allows for visualization of the corneal structures at the cellular level, allowing for assessment of corneal nerves. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Eligibility Criteria
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Inclusion Criteria
1. 18 years of age or older
2. Ability to consent
3. Best corrected visual acuity of 20/40 or better in each eye
Dry Eye Disease Group:
1. Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaire
2. Symptoms lasting at least 3 months
3. Presence of at least two of the following within the same eye:
1. Anesthetized Schirmer score =/\< 10mm
2. Corneal staining of \>3/15 based on NEI scale
3. Tear break up time \< 10 seconds
Neuropathic Corneal Pain Group:
1. Chief complain is ocular surface discomfort or dry eye disease
2. Symptoms lasting at least 3 months
3. All of the following in both eyes:
1. Corneal staining of less than or equal to 3/15 based on NEI scale
2. Tear break up time =/\> 10 seconds
4. Must have at least 25% peripheral pain
5. Subject reported discomfort prior to drop response testing of at least 3 out of 10
Control Group:
1. No symptoms of ocular surface discomfort or dry eye disease
2. All of the following in both eyes
1. Anesthetized Schirmer score \> 10 mm
2. Corneal staining of less than or equal to 3/15 based on NEI scale
3. Tear break up time \> 10 seconds
3. The same sex and within 5 years of age of a patient within the NCP group.
Exclusion Criteria
2. Irregular corneal disease
3. Ocular surgery in the past 3 months
4. Ocular infection in the past 3 months
5. Active ocular allergies
6. Participation in a study that could potentially impact the IVCM in the opinion of the investigator
7. Current use of corneal nerve regeneration therapy that has been on-going for 3 months or more.
8. For NCP group only, patients for whom their pain and symptoms can be attributed to other causes in the opinion of the investigator
18 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pedram Hamrah, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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Tufts Medical Center
Boston, Massachusetts, United States
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Fry HJ. Overuse syndrome, alias tenosynovitis/tendinitis: the terminological hoax. Plast Reconstr Surg. 1986 Sep;78(3):414-7. doi: 10.1097/00006534-198609000-00025. No abstract available.
Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs and symptoms in patients with dry eye disease. Cornea. 2004 Nov;23(8):762-70. doi: 10.1097/01.ico.0000133997.07144.9e.
Iuganov EM, Krylov IuV, Kuznetsov VS. [Use of psychophysiological indices in the practice of audiological studies]. Izv Akad Nauk SSSR Biol. 1971 Jul-Aug;4:587-95. No abstract available. Russian.
Sullivan BD, Crews LA, Messmer EM, Foulks GN, Nichols KK, Baenninger P, Geerling G, Figueiredo F, Lemp MA. Correlations between commonly used objective signs and symptoms for the diagnosis of dry eye disease: clinical implications. Acta Ophthalmol. 2014 Mar;92(2):161-6. doi: 10.1111/aos.12012. Epub 2012 Dec 28.
Nichols KK, Bacharach J, Holland E, Kislan T, Shettle L, Lunacsek O, Lennert B, Burk C, Patel V. Impact of Dry Eye Disease on Work Productivity, and Patients' Satisfaction With Over-the-Counter Dry Eye Treatments. Invest Ophthalmol Vis Sci. 2016 Jun 1;57(7):2975-82. doi: 10.1167/iovs.16-19419.
Fovaeus M, Andersson KE, Hedlund H. Calcium channel blockade and contractile responses in the isolated human vas deferens. J Urol. 1987 Sep;138(3):654-8. doi: 10.1016/s0022-5347(17)43292-7.
Classification of Chronic Pain, Part III: Pain Terms, A Current List with Definitions and Notes on Usage. Second ed. Seattle: IASP Press; 1994
Dieckmann G, Koseoglu N, Moein HR, Kataguiri P, Hamrah P. Epidemiological factors of neuropathic corneal pain. IASP: The 18th World Congress on Pain; 2018; Boston, MA.
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.
Lopez MJ, Jamali A, Dieckmann G, et al. Corneal Pain Has a Negative Impact on the Quality of Life of Patients with Neuropathic Corneal Pain. Investigative ophthalmology & visual science. 2018;59(9):138-138
Lopez MJ, Abbouda A, Pondelis N, et al. The Ocular Pain Assessment Survey and In Vivo Confocal Microscopy as Valuable Tools in the Diagnosis and Management of Patients with Corneal Neuropathic Pain. Investigative ophthalmology & visual science. 2017;58(8):1013-1013.
Other Identifiers
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STUDY00003018
Identifier Type: -
Identifier Source: org_study_id
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