Imaging of Conjunctival Microvasculature During Contact Lens Wear
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vision Disorders
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assessment of Bulbar Conjunctival Blood Flow Velocity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Assessment of Bulbar Conjunctival Blood Flow Velocity
Time Frame: 4 contact lenses will be tested over a period of 21 days.
Bulbar conjunctival microvascular responses among different types of contact lenses after a period of lens wear will be observed and evaluated for clinical relevance findings.