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Ophthalmology

Ophthalmology Clinical Research Support and Services

Leverage our experience: over 40 trials conducted specific to ophthalmology.

WCCT’s ophthalmology clinical research center continues to offer comprehensive, full-service research capabilities for conducting early clinical development in ophthalmology. Our studies are carried out in our unique Phase I units that are the only sites in the U.S. that offer overnight confinement, first-in-human (FIH), safety/PK and optimum ocular data collection proficiencies.

With overnight confinement, WCCT is able to keep patients in a controlled environment, collect comparative data pre- and post-dose, monitor diurnal changes and more.

We have two comprehensive outpatient facilities specific to ophthalmology research. Dr. Michael Sheety, the Medical and Surgery Director of Ophthalmology and Aesthetics at WCCT’s Ophthalmology Research Center, has a clinical practice that supplements our recruitment efforts. When managing a multi-site study opportunity, we can leverage our own site to gives us firsthand knowledge applicable to the management of the overall trial.

Trials are conducted by professionals with extensive experience in clinical research:
  • Dr. Michael Sheety
  • Dr. Bruce-Lyle (Glaucoma Specialist)
  • Dr. Valerie Pilon (optometrist aka OD)
    • Network of Ophthalmology sites (through Biopharm Clinical)
By finding sites based on previous studies, we have a strong indication of their success in enrolling certain populations.
  • Nationwide
  • Predictable enrollment

Ophthalmology Project Manager – Polly Neely

In such a niche field, roles can’t just be filled by title. Practitioners need to understand the therapeutic area and all its nuances. WCCT’s ophthalmology project managers have such experience.

Dr. Neely has a comprehensive set of skills to assist you:
  • Regulatory consulting and medical writing support experience
  • Cooperative approach with sponsors to develop clinical strategies based on previous data
  • Face-to-face FDA experience, including pre-IND meeting arrangements, prep and support
  • Protocol writing expertise:
    • In-house stats team
    • In-house data management
    • CTMS

Our Ophthalmology Clinical Research Center provides full-service research capabilities in the areas of:

  • Cornea and external disease
  • Uveitis
  • Vitreoretinal diseases
  • Glaucoma
  • Neuro-ophthalmology
  • Oculoplastics and pediatric ophthalmic conditions such as strabismus and amblyopia
Headed by Dr. Michael A. Sheety, Medical and Surgery Director of Ophthalmology and Aesthetics, WCCT’s Ophthalmology Research Center consists of:
  • One ophthalmology outpatient site location in Santa Ana, CA
  • One cosmetology/aesthetics outpatient site in Santa Ana, CA
  • One Phase I clinical pharmacology unit in Cypress, CA
  • One Phase I-IV clinical pharmacology unit in Costa Mesa, CA
  • Database of 10,000+ active patients
  • Network of 20+ referring ophthalmologists and optometrists throughout Southern California
  • Access 40,000+ patients through our ophthalmology/optometry referral network throughout Southern California
  • Six ophthalmology-trained investigators (four MDs, two ODs)
WCCT’s Ophthalmology Research Center performs a wide range of refractive, therapeutic and surgical interventions, including:
  • Computerized visual acuity assessment
    • ETDRS
    • Contrast sensitivity
    • Glare
    • Amblyopia treatment study (ATS)
    • Holladay automated contrast sensitivity system (HACSS)
  • Autorefractor/keratometry
  • Fundus photography (non-mydriatic, mydriatic, fluorescein angiography, indocyanine green angiography)
  • Optical coherence tomography of the:
    • lridocorneal angle
    • Cornea
    • Retina-macula
    • Optic nerve
  • Scanning laser polarimetry
  • Confocal scanning laser ophthalmoscope
  • Corneal topography (scheimpflug/piaceido slit-scanning)
  • Ultrasound pachymetry-corneal thickness measurement
  • Confocal microscopy
  • Specular microscopy
  • Automated threshold static perimetry of visual fields
  • Goldmann kinetic perimetry
  • Preferential hyperacuity perimetry
  • A-scan ultrasound biometry
  • B-scan ultrasonography of the eye and orbit
  • Electro diagnostics (ERG,EOG, VEP)
  • Multispectral retinal imaging
  • Macular pigment density testing
  • Impression cytology
  • Tear osmolarity testing (laboratory microanalysis of the tear fluid)
  • Color vision assessment (RGB Anomaloscope,D-15, FM-100, pseudoisochromatic plates, Farnsworth color vision testing)

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