Non-invasive Induction of Metaplasticity for Amblyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-40
SponsorBoston Children's Hospital
About this trial
The goal of this clinical trial is to determine the efficacy of flicker therapy as an adjunct therapy to treat amblyopia beyond the critical period in adolescents and adults aged 14-40 years who have amblyopia of ≥3 lines of interocular best-corrected (with glasses) visual acuity difference.
The main questions it aims to answer are:
* Does flicker therapy enable clinically meaningful and durable visual recovery from amblyopia? * Do flicker therapy-treated patients show a change in amblyopic eye visual acuity (lines)? Participants will undergo daily flicker therapy for 1 hour per day.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥14 and ≤40 years
Amblyopia associated with strabismus and/or anisometropia
Criteria for strabismus: must meet at least one of the following: heterotropia at distance and/or near with or without spectacle correction, history of strabismus surgery, documented history of strabismus that is no longer present and felt by the investigator could have caused the amblyopia
≥ 0.50 D difference in spherical equivalent between eyes
Disqualifiers
Myopia > -6.00 D spherical equivalent
Presence of associated findings that could cause reduced visual acuity
Nystagmus does not exclude the subject if the above visual acuity criteria are met
Treatment with topical atropine within the past 12 weeks
Trial design
Design model
Single group
Treatments tested in this trial
Flicker
DeviceThe device is intended for investigational use in children (14 years old and up) and adults with amblyopia to evaluate the once daily use (up to 2 hours) over the study period of 8 weeks. Key characteristics of the system include: * Non-implantable * Externally applied * No electrical stimulation delivered to the body * No invasive components or procedures * No life-sustaining or life-supporting function The device consists of a handheld, battery-powered controller, an eyeset, and a power charger. The device is intended for daily use at home.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Arm 1 - Flicker TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Amblyopic Eye Best-Corrected Visual Acuity (BCVA)
Change in visual acuity of the amblyopic eye after 8 weeks of flicker treatment
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Proportion of patients with resolved amblyopia
Proportion of participants achieving resolution of amblyopia, defined as visual acuity in the amblyopic eye of 20/25 or better, following 8 weeks of treatment.
Time frame
8 weeks2
Durability of amblyopic eye visual acuity response
The visual acuity in the amblyopic eye will be compared between the 8 week visit (when flicker therapy is discontinued) to the 16 week visit. This difference reflects the maintenance of visual acuity and will be analyzed and interpreted in the context of change at an individual level in response to flicker therapy between weeks 0 and 8. The proportion of subjects maintaining a ≥ 10 letters (2 lines) improvement in the amblyopic eye visual acuity will be calculated and a 95% confidence interval on overall change will be computed.
Time frame
From end of treatment at 8 weeks to end of follow-up at 16 weeks3
Change in stereoacuity
Change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test. The change in log arcseconds will be compared between groups. Aggregated results will inform how overall stereoacuity has changed, and the difference from baseline will be compared across treatment groups and timepoints.
Time frame
8 weeks and 16 weeks4
Quality of life measures using the Amblyopia & Strabismis Questionnaire
This measure assesses the quality of life deficits across four domains: functional vision, bothered by eyes/vision, social, and frustration/worry. It uses a 3-point frequency scale and Rasch-calibrated domain scores (0-100).
Time frame
Change from baseline at 8 weeks and 16 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Children's Hospital
Lead sponsor
Massachusetts Institute of Technology
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: