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Miami, Florida 33136


Purpose:

This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.


Study summary:

This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical coherence tomography (OCT) to image and characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.


Criteria:

Inclusion Criteria: - The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. - The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. - The subject must be at least 18 and not more than 70 years of age. - The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye. - The subject must have best corrected visual acuity of 20/25 or better in each eye. - The subject must be either a neophyte or a habitual and adapted wearer of soft contact lenses in both eyes. - The subject must have normal eyes (i.e., no ocular medications or infections of any type). - The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses. Exclusion Criteria: - Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). - Any ocular or systemic allergies or diseases that may interfere with contact lens wear. - Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. - Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia. - Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in-situ keratomileusis (LASIK), etc.). - Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. - Any ocular infection. - Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. - Monovision or multi-focal contact lens correction. - Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. - History of binocular vision abnormality or strabismus. - Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report). - Suspicion of or recent history of alcohol or substance abuse. - History of serious mental illness. - History of seizures. - Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)


NCT ID:

NCT02540122


Primary Contact:

Principal Investigator
Hong Jiang, MD, PhD
University of Miami


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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