A new clinical trial recruiting participants is set to evaluate the effectiveness of AmblyoFix, a binocular digital therapy, in managing unilateral amblyopia. Sponsored by Eyesight Electronics and Nour Pajouhan Shargh Eye Specialist Clinic, this study aims to advance treatment options for this prevalent visual impairment.
What changed?
The clinical trial announced on November 29, 2025, introduces AmblyoFix as a potential digital alternative to traditional patching therapy for unilateral amblyopia. This marks a significant step in expanding treatment options, fostering more adaptable and accessible interventions in the ophthalmology field.
Study details
Unilateral amblyopia, commonly known as “lazy eye,” affects visual performance in one eye. Conventional treatment usually involves occlusion therapy (patching), which often raises compliance challenges, particularly with younger patients.
AmblyoFix is a novel digital therapy that uses binocular vision techniques, providing an interactive therapeutic approach through digital devices. According to the trial sponsors, Eyesight Electronics and Nour Pajouhan Shargh Eye Specialist Clinic, the therapy aims to improve visual outcomes by stimulating binocular coordination and neural pathways effectively.
Key details include:
- Condition: Unilateral amblyopia.
- Interventions: AmblyoFix (digital binocular therapy) and conventional occlusion therapy.
- Recruitment: Currently open, aiming to enroll participants.
The trial seeks to establish clinical evidence on the safety, compliance, and efficacy of AmblyoFix compared to standard patching. Results will inform regulatory decisions, including potential market approval.
Who is affected?
This trial has implications for clinical teams, device manufacturers, and regulatory professionals. It also offers hope to patients seeking alternative amblyopia treatments. Healthcare providers should monitor outcomes closely as they may influence future treatment recommendations.
Frequently Asked Questions
- What is AmblyoFix?
It is a digital therapy designed to manage unilateral amblyopia using binocular coordination techniques. - Why is this trial significant?
It explores an innovative, compliance-friendly alternative to patching, addressing longstanding challenges faced in traditional therapy. - How can I participate?
Interested individuals can inquire directly with the sponsors listed on the ClinicalTrials.gov page. - What are the sponsors’ roles?
Eyesight Electronics and Nour Pajouhan Shargh Eye Specialist Clinic oversee research phases, regulatory compliance, and participant welfare.
Conclusion
This announcement underscores the ongoing evolution in amblyopia management technologies and the industry’s commitment to evidence-based solutions. AmblyoFix demonstrates potential for improving both patient outcomes and treatment adherence.
Disclaimer
This content is for informational purposes only and does not constitute legal advice. Clinicians and regulatory experts must consult official sources for detailed guidance.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07240311?term=medical+device