NCT06310252已完成不适用
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Intrastromal Implantation of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects - Long Term Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- An exploratory data collection project with no primary safety or effectiveness endpoints.
研究概览
简要总结
The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.
A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide informed consent, have signed the written informed consent form, and been given a copy.
- •Subjects must be willing and able to return for one scheduled follow-up examinations.
- •Subjects must have undergone implantation with the TCA under study protocol PRO-010 between April 24, 2019 and October 31, 2019.
排除标准
- •There are no known exclusion criteria.
结局指标
主要结局
An exploratory data collection project with no primary safety or effectiveness endpoints.
时间窗: 4 years or more after TCA implantation
An exploratory data collection project with no primary safety or effectiveness endpoints.
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen OvaleAtrial Septal DefectPatent Foramen OvaleNCT00207376Carag AG
已完成
不适用
A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia RepairHernia, VentralIncisional HerniaNCT02712398C. R. Bard120
终止
不适用
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior FixationDegenerative Disc DiseaseNCT02068768LDR Spine USA13
已完成
不适用
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault ProlapseUrinary Incontinence, StressMixed IncontinenceVaginal Vault ProlapseNCT00223106Medtronic - MITG467
已完成
不适用
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in ChinaPsoriasisNCT04894890Novartis Pharmaceuticals1,002