Closed Neuro-Ophthalmology Trials

 

Neuro-Ophthalmology: Long-Term Follow-up of the Cohort from a Multicenter, Double-Masked, Randomized, Placebo-Controlled Study of Weight-Reduction and/or Low-Sodium Diet plus Acetazolamide vs. Diet plus Placebo in Subjects with Idiopathic Intracranial Hypertension with Mild Visual Loss
PI:
Beau Bruce, MD, PhD
Coordinator:
Judy Brower
Status:
Completed

General Summary: This study is a 5-year follow up of the participants of a previous study (IIHTT) to determine long term frequency of remission, recurrence, and delayed worsening to better understand how to manage this potentially blinding disease. Long term vision, quality of life, and long term success and failure of the weight management program will be determined.

Inclusion Criteria: Participant in IIHTT (Idiopathic Intracranial Hypertension Treatment Trial)

Exclusion Criteria: Unwillingness to return for follow-up at participating study site.

Contact: Judy Brower, 404-778-4725
Posted: 03-12-2014; 06/18/2015

A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet plus Acetazolamide vs Diet plus Placebo in Subjects with Idiopathic Intracranial Hypertension with Mild Visual Loss

PI: Beau Bruce, MD, MS
Coordinator: Judy Brower, COMT
Status: Completed

General Summary: To determine whether weight reduction and/or low sodium diet plus acetazolamide vs. same diet plus placebo is effective in reversing or reducing visual loss.

Inclusion Criteria:
- Diagnosis of Idiopathic Intracranial Hypertension of less than 6 weeks.
- Age 18 - 60 at time of diagnosis.
- Bilateral papilledema.

Exclusion Criteria:
- Total treatment of IIH of more than one week in past six weeks.
- Corticosteroids used for IIH within past six weeks.
- Medical condition that would contraindicate use of acetazolamide (such as renal stones).
- Exposure to disorder, substance, or drug that has been asociated with elevaton of intracranial pressure within 2 months of diagnosis (such as steroid withdrawal, lithium, vitamin A, various cyclines).
- Previous surgery for IIH.
- Previous gastric bypass surgery.
- Abnormal neurological exam with excepton of papilledema and related visual loss or VI N palsy
- Abnormal MRI or CT scan other than flattened sclera, empty sella, unfolded optic nerve sheath, smooth-walled venous stenosis or secondary Chiari I Malformation.
- CSF pressure lass than 200 mm water.
- Refractive error > +/-6.00 sph or > +/-3.00 cyl in either eye
- Intraocular pressure currently > 28 or > 30 at any time in the past.
- Presence of diagnosed untreated sleep apnea.
- Type I diabetes or diabetic retinopathy.
- Condition requiring diuretics, oral, injectable, or I.V. steroids or other pressure lowering medication including topiramate (inhaled, nasal, or topical steroids are allowed because systemic effects are small).
- Use of corticosteroids, diuretics, topiramate for the treatment of IIH within 2 days of Baseline visit and during the study.

Contact: Judy Brower 404-778-4725
Updates:   11-30-10; 01-18-2013; 07-03-2013; 03-12-2014 Closed

 

Idiopathic Intracranial Hypertension Treatment Trial - Controls
PI: Beau Bruce, MD, MS
Coordinator: Judy Brower, COMT
Status: Closed

General Summary: Overweight women without Idiopathic Intracranial Hypertension needed for a single visit. Abbreviated medical history, 10 question questionnaire, weight, height, waist circumference, undilated eye exam, and blood sample will be obtained.

Inclusion Criteria: Overweight women between the ages of 18 - 60

Exclusion Criteria: Idiopathic Intracranial Hypertension

Contact: Judy Brower 404-778-4725
Posted: 01-18-2013
Updated: 07032013; 07082013

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