In an NIH-funded clinical trial, led at Saint Louis University by professor of ophthalmology Sophia Chung, M.D., researchers aim to bring sight back to those who have lost vision due to idiopathic intracranial hypertension (IIH).
IIH is a condition, of unknown origin, causing raised intracranial pressure primarily in obese women. Those with IIH suffer debilitating headaches, and, because of pressure on the optic nerves, 86 percent develop some degree of vision loss.
Around 100,000 Americans have IIH and the number is rising with the obesity epidemic. Of those with the disease, only 3 percent are men and most are women of childbearing age.
"IIH can be a debilitating condition, significantly diminishing quality of life," said Chung, who also is a SLUCare physician. "Because of vision loss, patients may have trouble with daily tasks, like driving and reading."
The NIH's National Eye Institute shared results from the first arm of the study earlier this year. Researchers were pleased to see that the combination of medication and weight loss not only preserved but also restored vision for many participants. Now, in the second stage of the trial, researchers will examine whether these benefits will last over time.
In the first part of the study, researchers tested whether a drug previously used for glaucoma and used for altitude sickness, acetazolamide, could improve mild vision loss when added to a weight loss program. Researchers at 38 sites enrolled 161 women and four men with IIH and mild vision loss and randomly assigned them to receive either the study drug or a placebo.
At the beginning of the study, the average BMI of participants was 40. All of those in the study were enrolled in weight loss plans aimed at losing six percent of their starting weight. Participants cut salt intake and 500 to 1000 calories a day, consulted with a weight loss coach, and were provided with simple exercise equipment.
The vision of patients receiving the drug improved by twice as much as those who received the placebo. Participants who both lost weight and took the medication had greater improvements in daily function and quality of life.
Now, in the second arm of the study, researchers will see if this drug and weight loss approach is a winning combination to manage symptoms over the long term. Researchers will follow participants for five years to see if their symptoms reappear and if they are able to maintain a healthy weight.