초록 ▼

세포 모델에서 저강도 초음파 최적화 조건을 확인하였으며, 녹내장 및 황반부종 세포모델 확립을 통해 이에 대한 저강도 초음파 치료기의 효과를 확인함. 또한 세포 모델에서 산화 스트레스에 대한 저강도 초음파의 보호 효과를 확인함.
Ultrasonic eye patch (UEP)를 개발하여 시뮬레이션을 통해 검증하였으며, 녹내장 및 황반부종 동물모델에서의 치료 효과를 확인함.
현재 실명한 녹내장 환자를 대상으로 2상 임상연구를 진행 중에 있으며, 현재까지의 결과 저강도 초음파치료기기를 이용한 치료는 치료 전 압압과 비교하였을

세포 모델에서 저강도 초음파 최적화 조건을 확인하였으며, 녹내장 및 황반부종 세포모델 확립을 통해 이에 대한 저강도 초음파 치료기의 효과를 확인함. 또한 세포 모델에서 산화 스트레스에 대한 저강도 초음파의 보호 효과를 확인함.
Ultrasonic eye patch (UEP)를 개발하여 시뮬레이션을 통해 검증하였으며, 녹내장 및 황반부종 동물모델에서의 치료 효과를 확인함.
현재 실명한 녹내장 환자를 대상으로 2상 임상연구를 진행 중에 있으며, 현재까지의 결과 저강도 초음파치료기기를 이용한 치료는 치료 전 압압과 비교하였을 때 안압 하강 효과를 나타내었으며, 이상반응 및 기타 검사 상 특이 사항 발견되지 않았으며 안전성에 문제가 없음.
아래는 본 연구의 총괄 성과임.
- 연구 논문 총 32 편 출간; 국외 SCI(E) 등재학술지 27 편, 국내 SCI(E) 비등재학술지 5 편
- 지식재산권 11 건 출원 및 등록; 국내 출원 5 건, 국내 등록 6 건
- 시제품개발 5건
- 인력지원 11명; 박사 3명, 석사 5명, 기타 3명
- 학술회의 1회 개최
- 해외 파견 인력 교류 1명
- 국제 협력 기반 수요 조사 1건
- 식약처 품목 승인 1건
- 임상시험 실시

Abstract ▼

Ⅰ. Purpose of the project
To develop a low-intensity ultrasound (LIUS) device for managing blinding ocular disease such as glaucoma and macular edema.
Ⅱ. Contents and extent of the project
1. Investigate the therapeutic effects of the LIUS device using animal models and cell lines, and rese

Ⅰ. Purpose of the project
To develop a low-intensity ultrasound (LIUS) device for managing blinding ocular disease such as glaucoma and macular edema.
Ⅱ. Contents and extent of the project
1. Investigate the therapeutic effects of the LIUS device using animal models and cell lines, and research on optimal intensity ultrasound and appropriate method of applying the treatment when regarding the safety and efficacy.
2. Research and understand the mechanism of ultrasound treatment modality on the cellular basis, and develop a target aiming device that selectively targets certain tissue or cell type that are critical in the treatment mechanism.
3. Develop an image supported target aiming LIUS device that can safely target and treat certain parts of the eye, and confirm its therapeutic effects on animal models.
4. Conduct a clinical trial using a LIUS device to confirm the treatment effects and its safety on glaucoma patients.
Ⅲ. Results of the project
The optimized condition of LIUS device in cell model was established, and its therapeutic effect in cell models of glaucoma and macular edema was observed in in vitro experiments. We developed a device called ultrasonic eye patch(UEP), and verified it through simulation tests. Therapeutic effects were observed when treated on animal models of glaucoma and macular edema.
Using the results from cell lines and animal models, we have developed a novel LIUS device, and provided a protocol for the clinical trial. After the approval from the ministry of food and drug safety, we are currently on phase 2 clinical trial to investigate the therapeutic and adverse effects of the device on patients blind from glaucoma. 9 patients are currently enrolled in this prospective, crossed designed, double-blinded, randomized controlled trial. No adverse events have been noticed, and reduction of intraocular pressure after the treatment was observed in the treatment arm, while the control arm did not demonstrate the intraocular pressure reduction.
Ⅳ. Utilizing plan of the results
By commercializing the developed low-intensity ultrasound device, we anticipate that it may replace or assist the current medical and surgical treatment for glaucoma, and expect it as a novel therapeutic modality for refractory glaucoma.
Moreover, it can lead to reduction of medical expense resulting in the improved access to healthcare institution for glaucoma patients, and furthermore preventing the blindness, which causes not only economic issues but also various social and psychological problems for the patients.