Pediatric Ophthalmology & Strabismus Clinical Trials

A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles plus Patching for Amblyopia in Children 3 to <13 Years Old (ATS22)
Study aims: The purpose of this study is to find out if treating amblyopia with glasses and patching at the same time improves vision as well as treating amblyopia first with glasses and then with patching, if needed.
Study design (clinical trial/observational study): Clinical Trial
Eligibility criteria: In general, to take part in this study, you must be 3 to < 13 years old. Also, you must not have been treated for amblyopia. Your study doctor and staff will review more health-related requirements with you.
Treatment arms: A computer program will be used to select whether you will start the study only wearing glasses and wear a patch later if needed or whether you will start the study by wearing glasses and a patch at the same time. This is like flipping a coin to decide which group you will be in.
Number of study visits: You will see your eye doctor about every 8 weeks for 56 weeks.
What participation involves (eg., costs/reimbursement to patient): If you take part in the study, you will receive up to $400 for your participation. These payments will be paid as follows: $40 for each completed visit (up to ten visits) by Amazon gift card.
Sponsor: National Eye Institute/ NIH (Pediatric Eye Disease Investigator Group/JAEB))
Dates of enrollment: February 2021- present
PI: Kammi Gunton, MD
Contact person/Study coordinator: Kieran Alessi ; 215 928 3113 ; kalessi@willseye.org

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)
Study aims: You are being asked to take part in this research study to find out if treating amblyopia with Luminopia is as good as treating amblyopia with patching. The goal of this study is to learn things that may help people with amblyopia.
Study design (clinical trial/observational study): Clinical Trial
Eligibility criteria: To take part in this study, you must be 4 to < 8 years old. You must not have any history of light-induced seizures. Your study doctor and staff will review more health-related requirements with you.
Treatment arms: A computer program will be used to select whether you will start the study wearing a patch or using Luminopia. This is like flipping a coin to decide which group you will be in.
Number of study visits: You will be asked to be in this research study for about 26 weeks. The study will involve you wearing your glasses (if you need them) and then being randomized to wearing either a patch or to using the Luminopia virtual reality headset. You will see your eye doctor at 13 weeks and 26 weeks.
What participation involves (eg., costs/reimbursement to patient): If you take part in the study, you will receive up to $500 for your participation.
Sponsor: National Eye Institute/ NIH (Pediatric Eye Disease Investigator Group/JAEB))
Dates of enrollment: March 2025- present
PI: Kammi Gunton, MD
Contact person/Study coordinator: Kieran Alessi ; 215 928 3113 ; kalessi@willseye.org

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age (ATS24)
Study aims: This study is being done to compare 3 different treatments for amblyopia – (1) optical correction (like wearing eye glasses) alone, or (2) optical correction (if needed) and watching shows using a virtual reality headset (Luminopia), or (3) optical correction (if needed) and playing games using a virtual reality headset (Vivid Vision).
Study design (clinical trial/observational study): Clinical Trial
Eligibility criteria: To take part in this study, you must be 8 to < 13 years old. You must not have any history of light-induced seizures or simulator sickness. Your study doctor and staff will review more health-related requirements with you.
Treatment arms: A computer program will be used to select whether you will start the study wearing glasses only (if you need them), or whether you will also use Luminopia or Vivid Vision. There is an equal chance of you being in one of these three groups.
Number of study visits: You will be asked to be in this research study for about 18 weeks. You will see your eye doctor at 9 weeks and 18 weeks.
What participation involves (eg., costs/reimbursement to patient): If you take part in the study, you will receive up to $500 for your participation.
Sponsor: National Eye Institute/ NIH (Pediatric Eye Disease Investigator Group/JAEB))
Dates of enrollment: March 2025- present
PI: Kammi Gunton, MD
Contact person/Study coordinator: Kieran Alessi ; 215 928 3113 ; kalessi@willseye.org