Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Case Crossover Study

Inclusion Criteria:

Patients must meet all criteria to be eligible for the study:

1. NAION onset within 4 weeks before entry to the study defined as including all of the following: a) visual field defect consistent with optic neuropathy, b) relative afferent papillary defect (RAPD) unless prior optic neuropathy or retinopathy, and c) optic disc edema
   
2. NAION onset definable by the subject within a 2 calendar day window. If the subject specifies an exact day of onset, the risk period will include that day and the proceeding day.
3. Men with a history of ED at least one (1) year prior to enrollment. ED should have been diagnosed by a physician before entry to the study. No scores to assess severity will be used at study entry.
4. Have taken at least one (1) dose of PDES inhibitor(s), based on a sample or prescription, at any time in the one (1) year prior to enrollment in the study and prior to the onset of loss of vision.
5. Age 40 years and older.
6. Ability to complete a phone interview and recall history accurately.
7. Documented, signed and dated written informed consent.

Exclusion Criteria:

Medical:

1. History of Multiple Sclerosis (MS) or suggestive of MS (probable or possible MS) or optic neuritis or any of the following symptoms or signs suggestive of these diagnoses: a) pain on motion of the globe within 3 days of loss of vision, b) marked recovery of field of loss of vision and, c) marked delays on visual evoked potential
2. Evidence of temporal arteritis, as indicated by any of the following findings: a) positive temporal artery biopsy, b) jaw claudication or temporal tenderness, c) polymyalgia rheumatica, d) high ESR (>40mm/h), platelets (>400 x 109 L) and/or CRP (>10mg/dL) and, e) large cup in fellow eye with a >50% cup to disc ratio
3. History of vasculitis or collagen vascular disease (e.g. systemic lupus erythematosus, polyarteritis nodosa) or any other inflammatory disease associated with arteritic ischemic optic neuropathy (AION) or disc swelling.
4. Evidence of elevated intracranial pressure
5. Use of PDES inhibitors from other than a sample or prescription

Ophthalmological:

1. Any of the following orbital signs: proptosis or resistance to retropulsion which may be associated with Graves eye disease or Graves-related exophthalmos, arterialized conjunctival vessels, choroidal folds or orbital mass
2. Ocular inflammation that may be associated with any of the following conditions: iritis or vitritis, evidence of active sarcoidosis or evidence of active syphilis
3. Acute glaucoma or intraocular pressure (IOP) >30mmHg
4. Retinal vein occlusion
5. Previous history of NAION
6. Retinal detachment
7. Uveitis
8. Lens opacities (which prevent an adequate examination)
9. Use of any drugs known to affect the optic nerve or retina that cannot be excluded

Please send your patients to:
Dr. Rosa Tang, MD, MPH, MBA
MS Eye Care at The University Eye Institute
4901 Calhoun Rd, UH Entrance 2
Houston, Texas 77204
Phone: 713-942-2187
Fax: 713-942-0265

Call to schedule an appointment or download this form and fax it to us!
(please write NAION STUDY under referral reason)

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