Greater than 20 years after the launch of a landmark medical trial, follow-up examinations and analyses discovered that not all sufferers with elevated eye stress want pressure-lowering remedy to forestall imaginative and prescient loss from glaucoma.
When the research was launched, it was universally accepted that each one sufferers with elevated eye stress needs to be given treatment to decrease that stress. The Ocular Hypertension Therapy Research -; funded by the Nationwide Eye Institute of the Nationwide Institutes of Well being (NIH) and led by researchers at Washington College Faculty of Drugs in St. Louis -; recruited greater than 1,600 sufferers nationally who had been at average to excessive danger for glaucoma due to elevated eye stress. The aim was to judge how profitable treatment was at preserving imaginative and prescient.
Half of the sufferers had been randomly chosen to obtain every day remedy with eye drops to decrease intraocular stress, and the opposite half had been noticed with out remedy. After seven years, when the remedy had been proven to be extremely efficient, sufferers in each teams got the remedy. On this newest part of the research, researchers evaluated which sufferers went on to develop glaucoma after the preliminary research had concluded.
As reported on-line April 15 within the journal JAMA Ophthalmology, the researchers discovered that about 25% of research members went on to develop imaginative and prescient loss from glaucoma in not less than one eye, a decrease fee than what was anticipated. The traditional considering had been that the majority sufferers with elevated eye stress in all probability ought to obtain remedy.
However treating elevated eye stress could be costly and inconvenient, so we needed to find out whether or not all people with excessive stress needs to be handled. With solely 25% of the people within the research growing imaginative and prescient loss in a single or each eyes in any case these years, we all know now that not all of these sufferers wanted to be handled.”
Michael A. Kass, MD, the Bernard Becker Professor of Ophthalmology & Visible Sciences
Glaucoma is without doubt one of the main causes of blindness in the USA and the No. 1 reason behind blindness in Black People. Elevated eye stress develops in 4% to 7% of the individuals in the USA over age 40, and the standard knowledge previous to the research had been to prescribe pressure-lowering drops. However these medicines can value a whole bunch of {dollars} per yr; they will trigger unwanted side effects in some individuals; and many individuals, particularly older people, discover it troublesome to place drops of their eyes day-after-day.
Fluid within the eye frequently flows out and in. Elevated stress outcomes when the fluid drains too slowly.
Within the preliminary part of the research, the incidence of glaucoma fell considerably in those that acquired remedy.
“We confirmed that preventive remedy clearly works as a result of it lowered the incidence of glaucoma by 50% to 60% after 5 to seven years,” mentioned Kass, who served as nationwide chair of the research. “However even with that substantial lower, the whole quantity of people that developed glaucoma remained comparatively low. We had proven that remedy is efficient, and we demonstrated that not everybody with excessive eye stress must be handled.”
The follow-up evaluation sought to uncover patterns and danger elements to determine which sufferers wanted pressure-lowering remedy and which could merely require monitoring. Of the research members, 46% had proof of glaucoma in a single or each of their eyes, however solely 25% had skilled any imaginative and prescient loss when examined 20 years after the research’s launch.
“One of many strengths of our research was that about one-quarter of the sufferers we adopted had been Black, a gaggle with a better incidence of visible loss from glaucoma,” mentioned Mae O. Gordon, PhD, a professor within the John F. Hardesty, MD, Division of Ophthalmology & Visible Sciences and within the Division of Biostatistics, who led the information evaluation for the nationwide research. “We discovered that over the course of the research, greater than half of the African American sufferers did develop indicators of illness. Nonetheless, Black people had related outcomes to individuals from different teams after they had been matched for a similar ranges of danger.”
Early within the research, the researchers recognized 5 elements that predicted which sufferers had been at larger danger for growing glaucoma. These elements -; confirmed by the follow-up evaluation -; had been helpful in deciding how typically sufferers must be examined and whether or not they may profit from preventive remedy.
These elements are a affected person’s age; degree of intraocular stress; thickness of the cornea; a measurement of the looks of the optic nerve head; and one other measurement derived from normal visible discipline assessments.
Kass mentioned when these elements are quantified, it is clear many sufferers with elevated stress could be managed by common monitoring and will not require remedy. He mentioned the long-term research demonstrates that sufferers and their medical doctors can work collectively to resolve whether or not and easy methods to start remedy to decrease eye stress and that discovering the most effective course for treating individuals with excessive intraocular stress just isn’t a one-size-fits-all proposition.
“Elevated stress within the eye ought to begin a dialog between medical doctors and sufferers to find out the most effective strategy,” Kass mentioned.
The research additionally confirmed that the dangers related to delaying the beginning of drug remedy are comparatively low. Individuals randomly assigned to commentary within the early part of the research, earlier than switching to pressure-lowering drops afterward, had solely a barely larger danger of imaginative and prescient loss after 20 years than those that used pressure-lowering eye drops from the beginning of the research.
“We will delay pressure-lowering remedy till early injury is detected, and it does not appear to adversely have an effect on long-term outcomes,” Kass mentioned.
Kass, MA, et al for the Ocular Hypertension Research Group. Evaluation of cumulative incidence and severity of major open-angle glaucoma amongst members within the Ocular Hypertension Therapy Research after 20 years of follow-up. JAMA Ophthalmology, printed on-line April 15, 2021.
Supply:Washington College Faculty of Drugs in St. LouisJournal reference:Kass, M.A., et al. (2021) Evaluation of cumulative incidence and severity of major open-angle glaucoma amongst members within the Ocular Hypertension Therapy Research after 20 years of follow-up. JAMA Ophthalmology. doi.org/10.1001/jamaophthalmol.2021.0341.