Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06165705 |
Other study ID # |
ABCD CureSight |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2023 |
Est. completion date |
December 31, 2025 |
Study information
Verified date |
January 2024 |
Source |
Alaska Blind Child Discovery |
Contact |
Robert W Arnold, MD |
Phone |
9075611917 |
Email |
eyedoc[@]alaska.net |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Patients with visual acuity and ocular characteristics outside the Novasight FDA multi-center
study are to perform the same Curesight procedures- including M&S EVA or eETDRS patched
acuity, stereo and then utilize the Curesight device 1.5 hours per day, 6 days per week over
3-6 months to determine treatment efficacy.
An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized
Clinical Trial T. Wygnanski-Jaffe, B. J. Kushner, A. Moshkovitz, M. Belkin, O. Yehezkel and
G. CureSight Pivotal Trial Ophthalmology 2023 Vol. 130 Issue 3 Pages 274-285
Description:
Patients with visual acuity worse than 20/30 due to amblyopia will be offered therapy with
Curesight. The Curesight-component of amblyopia therapy will be offered no-charge for up to 4
months. The Curesight device must then be returned to Alaska Blind Child Discovery.
The Curesight device will be administered in a similar, safe manner as the previous
multi-centered trial that was performed in Israel and the US.
Patient Selection Inclusion criteria: patients aged 3 to less than 19 years. Amblyopia may be
due to refractive error, strabismus and/or deprivation.
Exclusion criteria: Inability to participate with any form of monocular visual acuity testing
and stereopsis testing. Light-induced seizures. Lack of any internet at home. Pregnancy.
Recruitment: Patients will be recruited from within Alaska Children's EYE & Strabismus
clinical practice. Patients will not be paid for recruitment. Patients will have opportunity
to review the publication regarding the study1.
Protocol (from Curesight Pivotal Trial NS-00706-R01) Binocular CureSight Treatment CureSight™
is an eye-tracking-based, dichoptic system aimed for the treatment of amblyopia under
dichoptic conditions. The technology is based on real-time eye tracking and separation of the
visual stimuli presented on a monitor into two separate digital channels, one for each eye.
Using this dichoptic method, any online content can be tailored individually per eye and then
presented simultaneously to each eye. During the treatment, dichoptic anaglyph glasses that
are part of the CureSight™ system have to be worn over the habitual spectacle correction. In
short, the technology has 2 main components: 1. Eye-tracker and anaglyph glasses that allow
continuous gaze position tracking for each eye and image presentation in the optimum position
to each eye, including cases of eye deviation and 2. Software that blurs the non-amblyopic
eye's central image area (i.e., the fovea), thereby forcing the visual system to use the
information from the amblyopic eye's fovea. The expected treatment outcome is significant
improvement in the amblyopic eye's visual acuity and in stereo vision (stereopsis).
Subjects assigned to the binocular treatment group will be prescribed the CureSight treatment
to watch for ≥90 minutes per day, 5 days a week for 16 weeks for the total of <120 hours.
Parents of subjects will be instructed that the 90 minutes of daily treatment should be
completed in a single 90- minute session, but if this is not possible for whatever reason,
the treatment may be divided into two shorter sessions totaling 90 minutes per day Subjects
in the treatment group will be asked to watch digital content presented on CureSight system
while wearing red/blue (anaglyph) glasses over current spectacle correction, if applicable.
The subject should be instructed to sit in front of the system at the distance of ~60 cm.
Positioning algorithm will automatically guide the subject to the optimal position.
Each subject will be supplied a pair of anaglyph glasses according to his/her amblyopic eye,
red filter should be positioned in front of the non-amblyopic eye and the blue in front of
the amblyopic eye.
In addition to the blur effect, the amblyopic eye image seen by the blue filter will have a
higher intensity compared to the dominant eye red image due to the nature of the channel
separation. The diameter and magnitude of the blur are adjusted during the treatment
according to the VA improvement of the amblyopic eye.
In addition to the blur effect, the amblyopic eye image seen by the blue filter will have a
higher intensity compared to the dominant eye red image due to the nature of the channel
separation. The diameter and magnitude of the blur are adjusted during the treatment
according to the VA improvement of the amblyopic eye.
Adverse Event Monitoring All adverse events which occur during the study will be reported,
regardless of whether or not they are considered to be related to treatment. The following
anticipated adverse events will be specifically monitored in both the therapeutic
1. Risks relating to amblyopia treatment
- Diplopia
- New/worsening heterotropia of greater than 10 prism diopters
- Worsening of BCVA in either eye of 2 logMAR lines or greater from baseline
2. Risks relating to technological usage
- Headaches
- Eye strain
- Skin irritation
Device deficiency Inadequacy of a medical device with respect to its identity, quality,
durability, reliability, safety or performance. Including: device malfunctions, use errors,
inadequate labelling of the device.
Potential device deficiencies may include:
- wrong blur position due to of eye tracker or calibration failure
- software failure
- Hardware failure; anaglyph glasses, eye tracker, computer.
- Use error such as wrong lens position, dirty lens. Risks/ Benefit discussion Standard of
care treatment for amblyopia comes with the accepted risks of developing a new/worsening
heterotropia or diplopia. However, the risk of developing new/worsening heterotropias or
developing diplopia from the CureSight therapeutic is expected to be no greater than it
would be with standard of care. In a 2016 study comparing binocular treatment to
patching, the rate of new heterotropias was 8.8% in the binocular group and 5.9% in the
patching group, a statistically and clinically insignificant difference. The same study
showed that diplopia was rare after both treatments The procedures to be conducted in
the study during visits are part of daily eye-care practice and pose no known risks. As
part of a routine eye-care exam, the participant may receive cycloplegic eye drops.
The participants in both groups will be unable to perform any amblyopia treatment other than
the intervention they are prescribed for the duration the study.
The diagnosis and management of reverse amblyopia is left to the investigator's judgment.
Given the relatively short study duration of 16 weeks, it is believed that the risk of
delaying standard of care treatment is minimal and justified.
acuity in any previous study of 2 hours of daily patching. This current proposed study is not
a randomized clinical trial.