Recruiting New Subjects for Clinical Trials
The CHAPERONE Study
Nearsightedness, or myopia, is a condition that results in blurry vision when looking at distant objects. Myopia happens when the eyeball grows too long or the cornea (the clear front cover of the eye) is too curved. As a result, light entering the eye is not focused correctly. While glasses and contact lenses can help a person with myopia see clearly, they do not address the underlying stretching of the eye. Myopia is usually detected in young children and tends to increase through the school years. As myopia progresses, so does the risk of retinal detachment, cataracts, myopia maculopathy and even blindness. This is why researchers are working to develop new medications and technologies that may help slow the progression of myopia in children and adolescents.
The CHAPERONE Study is testing 2 different strengths of microdosed atropine eye solution for slowing the progression of myopia in children. Atropine eye drops are currently approved by FDA in the US to treat lazy eye; however, the medication is considered investigational in the CHAPERONE Study because it has not been approved specifically for reduction of myopia progression. In the CHAPERONE Study, a gentle mist is sprayed into each eye using a specialized dispenser. Each mist of the medication is about ¼ the volume of an eye drop. Participants in the CHAPERONE Study will use the study medication in both eyes every night, about one hour before bedtime. For more information, please contact Jasmine Campbell, clinical research coordinator, at 215.276.6034 or email at email@example.com.
CHAMP: Children Who Are Nearsighted
Children ages 3 to ≤ 17 who are nearsighted are needed for a 4 year study to determine if a daily investigational eye drop slows the progression of nearsightedness (myopia). Children are randomly assigned to study drug treatment or placebo eye drops; any child assigned to placebo drops during the first 3 years will receive study drug treatment drops in the final year of the study. Participants will complete visits for follow-up (every 6 months) and to pick up study eye drops (every 3 months). Participants receive study related eye care and drops at no cost as well as a yearly allowance towards eyeglasses/contact lenses and reimbursement for travel expenses. For more information, please contact Karen Pollack at 215.276.6053 or email at firstname.lastname@example.org.
INTERMITTENT EXOTROPIA STUDY 6 (IXT6)
A Pilot Randomized Clinical Trial of Base-in 9 Prism Spectacles for Intermittent Exotropia.
This study is being conducted by the Pediatric Eye Disease Investigator Group (PEDIG) and is funded through a cooperative agreement from the National Eye Institute. It is one of a series of randomized trials and observational studies conducted by PEDIG that address management of intermittent exotropia (IXT) in children. The objective of this short-term, pilot randomized trial comparing spectacles with prism to spectacles without prism.
- Age 3 to < 13 years 367
- Intermittent exotropia
- No previous treatment for intermittent exotropia
- No previous sue of prism spectacles
Binocular Binocular Dig Rush Game Treatment for Amblyopia (ATS 20)
The study is being conducted by the Pediatric Eye Disease Investigator Group (PEDIG). Salus University is a member of this group. The study will include over 500 children at pediatric eye centers across North America and Europe. The National Eye Institute is providing the funding for the study.
Amblyopia is the most common cause of monocular visual impairment in children. The most common way of treating amblyopia is by patching the good eye. Recently, a new way of treating amblyopia has been developed. It involves using both eyes together (binocularly) to play a falling-blocks game on an iPad®. Some initial studies have shown that this new treatment may work well in some children and adults. We are conducting a clinical trial to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
Currently, we are recruiting children with amblyopia who are 5 to less than 17 years old.
- Visual acuity in the amblyopic eye between 20/40 and 20/200
- Random assignment to either:
- 1 hour/day of binocular iPad treatment, 7 days per week, OR
- 2 hours of daily patching treatment, 7 days per week
- Follow-up visits at 4, 8, 12 and 16 weeks
- At the end of the study (after 16 weeks of treatment), children who are randomly assigned to patching will be offered the opportunity to try the binocular iPad treatment for 16 weeks (outside of the study).
For more Information contact:
- Jasmine Campbell, Study Coordinator at: 215.276.6034
- Karen Pollack, Study Coordinator at: 215.276.6053