Shanghai Eye Disease Prevention and Treatment Center launches a clinical trial to study LED red light therapy as a device for modulating choroidal microcirculation in pathological myopia.
With retinal atrophy remaining a significant medical challenge for those suffering from pathological myopia, researchers in Shanghai aim to investigate the potential benefit of non-invasive LED red light therapy. This study may provide crucial insights for clinical, quality, and regulatory teams monitoring innovation in medical devices.
In this article:
- What changed?
- Clinical trial details
- Implications for medical devices
- Frequently asked questions
- Conclusion
- Disclaimer
- Full announcement link
What changed?
The Shanghai Eye Disease Prevention and Treatment Center has initiated a clinical trial titled “LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia.” The study is actively recruiting participants and will compare the effects of LED red light therapy with a sham equivalent, providing data to assess its efficacy and safety for medical device applications.
Clinical trial details
Key conditions under study
Pathological myopia is the primary condition targeted in this trial. It significantly affects eye health, particularly causing complications such as retinal atrophy. Addressing this condition requires novel approaches where modulating choroidal microcirculation is critical.
Interventions being tested
The trial employs two interventions:
- LED Red Light Therapy: This device aims to improve blood circulation in the choroid, potentially preventing or slowing retinal damage.
- Sham LED Red Light Device: Used as a control to determine the specific impact of active intervention.
Both devices are non-invasive and align with regulatory requirements for clinical device testing.
Recruitment status
Recruitment is described as active, confirming opportunities for eligible participants to contribute to innovation in myopia treatment.
Implications for medical devices
This clinical trial holds significance for medical device regulation and development:
- Data Generation: Results will contribute to understanding performance parameters and benchmarks for LED light-based therapies.
- Regulatory Feedback: Findings could influence future pathways for non-invasive devices targeting eye health.
- Safety Assessment: Evaluation of device safety against medical device standards will bolster credibility.
Device manufacturers and regulatory professionals should monitor these developments closely.
Frequently asked questions
- What is the projected outcome of the study?
The study aims to determine whether LED red light can effectively modulate choroidal microcirculation and slow retinal atrophy progression. - Who sponsors the trial?
The trial is sponsored by the Shanghai Eye Disease Prevention and Treatment Center. - How can participants enroll?
Interested individuals can access enrolling information via ClinicalTrials.gov using the provided link: ClinicalTrials. - Does the trial meet ethical standards?
Yes, clinical studies listed on ClinicalTrials.gov must adhere to strict ethical and scientific standards.
Conclusion
This clinical trial investigating red light therapy devices for pathological myopia represents an opportunity to advance treatment options for a challenging eye condition. Whether through its contribution to regulation standards or innovative device technology, its outcomes may reshape approaches to retinal health.
Disclaimer
This article is intended for informational purposes for clinical, quality, and regulatory professionals. It is not legal advice and should not substitute professional consultation.
Full announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07312214?term=medical+device