Clinical Research Through the Eyes of the Ophthalmologist

Oral presentation

I. What is Special about the Eye?

· A paired organ made up of two embryonic tissues – Ectoderm and Mesoderm

· It is a window for systemic as well as local disease manifestation

· There are many disorders limited to the eye

· Delegation of assessments and management is rare

II. Problems areas in Ophthalmologic research

· Difficulty in "masking" studies (term "blinded" not used)

· How to quantitate qualitative data (hard data from soft endpoints)

· Retinopathy grading systems e.g. for ASCVD, DM, HHD

· The need to train observers (consistency of qualitative data)

· The need to standardize definitions and nomenclature

· Comparing data from old with that from new technology

· Margin for error is smaller than with other organ systems

· Rarity of some conditions requires multicenter studies

· Natural history of many conditions unknown as they show and are treated early

III. Drug Studies and the eye

· Ocular pharmacology – more than just miosis and mydriasis

· Getting the drug to the eye (gtts. vs. implantable slow release devices)

· Measuring ocular irritation – 12 point MacDonald Shadduck system

· Photodynamic therapy

IV. Disorders Limited to the Eye

· Glaucoma (hypertension of the eye?) a generic term & a variable population

· Refractive disorders and the role of radial keratotomy

· Retinal diseases (detached retina, macular degeneration)

· Tumors such as retinoblastomas, etc.

· Corneal disorders (corneal ulcers, keratitis, staining, opacification, …..)

· Disorders of the Lens (cataracts)

· Intraocular inflammatory disorders and infections

V. Systemic conditions observed through the eye (Color Atlas of the Eye in Systemic Disease; Gold and Weingeist, Eds, 2001 Lippincott Williams & Wilkins)

· Hypertension – Hypertensive Retinopathy

· Diabetes Mellitus – Diabetic Retinopathy

· ASCVD / Hypercholesterolemia – Retinopathy

· Hyperthyroidism / Hypothyroidism – many eye findings

· Hyperparathyroidism – Corneal band keratopathy

· Anemia / polycythemia – hypoemia / hyperemia

· Leukemia's – typical retinopathy

· AIDS – CMV Retinitis

· Autoimmune / Immunological diseases – vasculitis

· MS – Optic Neuritis

· Numerous (hundreds) syndromes with eye involvement

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