Post-Market Study for the Evaluation of the Efficacy and Safety of the OpHLINE Ophthalmic Viscosurgical Device (OVD) in Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Ability to maintain anterior chamber space during cataract surgery.
研究概览
简要总结
This post-market clinical study was designed to assess the safety and effectiveness of the OpHLINE Ophthalmic Viscosurgical Device (OVD) as an adjunct in cataract surgery. OpHLINE is a sterile, viscoelastic solution based on high-molecular-weight sodium hyaluronate, intended to maintain the anterior chamber space and protect corneal endothelial cells during phacoemulsification and intraocular lens (IOL) implantation.
The hypothesis is that OpHLINE, available in three concentrations (1.4%, 2%, and 3%), will provide optimal space maintenance throughout all surgical phases-capsulorhexis, hydrodissection, phacoemulsification, and IOL insertion-while ensuring ease of removal and minimizing postoperative complications. Specifically, the study expects the device to demonstrate high biocompatibility, effective protection of corneal endothelial cells, and a low incidence of adverse events, including intraocular pressure (IOP) spikes.
The objectives include confirming compliance with current clinical performance standards and collecting surgeons' feedback on handling and usability. This evaluation aims to strengthen real-world evidence supporting OpHLINE as a safe and reliable solution for cataract surgery, ensuring patient safety and surgical efficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older scheduled for cataract extraction by phacoemulsification, followed by implantation of a posterior chamber intraocular lens (IOL) in a single eye (operative eye).
- •The non-operative eye must be functional, as assessed by the investigator.
排除标准
- •Ocular hypertension (IOP ≥ 22 mmHg).
- •Corneal endothelial damage (cell count < 2000 cells/mm²).
- •History of chronic or recurrent ocular inflammatory disease.
- •Chronic or recurrent uveitis.
- •Acute ocular disease.
- •Internal or external ocular infection.
- •Glaucoma or proliferative diabetic retinopathy.
- •Previous ocular trauma before surgery.
- •Congenital ocular anomalies or iris atrophy.
- •Any other ocular pathology or physiological condition that could be worsened by cataract surgery.
- •Previous ocular surgery.
研究组 & 干预措施
OpHLINE® 1.4%
Patients undergoing cataract surgery received the OpHLINE OVD with 1.4% sodium hyaluronate. This formulation is designed to maintain the anterior chamber space and protect corneal endothelial cells while offering easier removal due to its lower viscosity.
干预措施: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 1.4%) (Device)
OpHLINE® 2%
Patients in this group were treated with the OpHLINE OVD containing 2% sodium hyaluronate. This intermediate concentration aims to provide enhanced space stability during surgical phases while balancing protection and handling characteristics.
干预措施: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 2%) (Device)
OpHLINE® 3%
This group received the OpHLINE OVD with 3% sodium hyaluronate, the highest concentration tested. It is intended to maximize space maintenance and tissue protection during surgery, though it may require more effort for removal due to its higher viscosity.
干预措施: Cataract Surgery by Phacoemulsification with Posterior Chamber Intraocular Lens Implantation (OpHLINE 3%) (Device)
结局指标
主要结局
Ability to maintain anterior chamber space during cataract surgery.
时间窗: 90 days
This outcome evaluates whether the OpHLINE OVD can maintain a stable and adequate anterior chamber throughout all critical phases of cataract surgery: capsulorhexis, hydrodissection, phacoemulsification, and intraocular lens (IOL) insertion. Surgeons assessed this parameter using a structured questionnaire, classifying the chamber status into four categories: Complete chamber, Adequate working space, Shallow chamber, and Flat. A positive outcome is defined as achieving either a complete chamber or adequate working space in at least 70% of cases. This measure reflects the core functionality of the OVD in providing surgical safety and facilitating precise maneuvers.
Safety evaluation of OpHLINE during and after surgery
时间窗: 90 days
This measure involves systematic monitoring and documentation of any serious adverse events related to the device during the entire study period. SAEs include any event that could result in significant harm or require medical intervention. The target is an incidence rate of ≤1%, confirming that the device does not introduce unexpected risks beyond those inherent to cataract surgery.
次要结局
- Assessment of removal difficulty after IOL implantation(6 hours)
- Percentage of endothelial cell density loss(90 days)
- Incidence of IOP ≥30 mmHg during follow-up(90 days)
- Frequency of non-serious adverse events during follow-up(90 days)