A prospective, comparative, randomized, post marketing clinical study of two phakic implantable lenses to compare outcomes in patients with moderate to high myopia.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- To evaluate and compare the efficacy and the residual refractive error of EYECRYL
研究概览
简要总结
The objective of the post-marketing clinical study is to compare the performance and safety outcomes of EYECRYL Phakic IOL (Biotech Vision Care), with Visian ICL (STAAR Surgical) in patients with moderate to high myopia. Treating moderate to high myopia treatment poses challenges, as traditional glasses and contact lenses often fall short, and laser vision correction may not be safe for severe cases. Phakic IOLs, which are placed inside the eye without removing the natural lens, offer an alternative that preserves corneal structure, making them suitable for patients with moderate to high myopia who cannot undergo corneal refractive surgery. This study assesses the long-term safety and effectiveness of EYECRYL, Phakic IOL and Visian ICL TM (STAAR Surgical), focusing on complications (e.g., cataract risk, endothelial cell loss) and visual outcomes like acuity, stability, and quality, especially for high myopia. By comparing these lenses, the study aims to identify which design aspects (e.g., anterior vs.posterior chamber placement) yield better patient outcomes, informing best practices.
Additionally, the research supports personalized treatment approaches, allowing clinicians to select implants based on patient-specific factors, such as corneal thickness and eye health. These findings could enhance confidence in post-marketing surveillance and offer transparent evidence for both clinicians and regulatory bodies on the real-world performance of PILs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients 21 years.
- •Calculated IOL Power is within the range of the study IOLs.
- •The ACD from endothelium is between 2.80 mm and 4.50 mm.
- •The white to white (WTW) is either between 9.56 mm and 10.52 mm or between 12.15 mm and 12.92 mm.
- •Subject falling under spherical power range of 0 D to -25.0 D.
- •Subject has monocular UDVA 0.5 LogMAR or worse.
- •Subject has had stable refraction history (within 0.5 D each for spherical power and cylindrical power) for a minimum of 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
- •The subject, who is a current contact lens wearer, needs to demonstrate stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates, and stability of the refraction is determined by the following criteria: a.
- •Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
- •Two refractions were performed at least 7 days apart.
- •The subject, who is expected to have the residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
- •Patients must sign and be given a copy of the written Informed Consent Form.
- •Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner use effective contraception during the study.
排除标准
- •Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- •The subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject.
- •Subject with ocular condition that may predispose the subject to future complications.
- •Subject with previous intraocular or corneal surgery.
- •Subject with less than the minimum endothelial cell density of 2000 cells/mm² at the time of enrollment.
- •Pregnant or planning to become pregnant, or is lactating during the course of the evaluation.
- •Other conditions associated with fluctuation of hormones.
- •ACD measured from the endothelium lower than 2.8 mm.
- •Concurrent participation in another drug or device evaluation.
- •Cataract of any grade.
- •Coefficient of variation of endothelial cell area greater than 0.
- •Percent Hexagonality of endothelial cell shape less than or equal to 45%.
- •Monocular subject.
- •Vulnerable subjects as defined in section 11.3.10.
结局指标
主要结局
To evaluate and compare the efficacy and the residual refractive error of EYECRYL
时间窗: 1, 3, 6 & 12 months Post-operative
TM Phakic IOL versus Visian ICL TM in moderate to high myopia patients
时间窗: 1, 3, 6 & 12 months Post-operative
次要结局
- To evaluate and compare the safety of EYECRYL TM Phakic IOL versus Visian ICL TM in moderate to high myopia patients.(1, 3, 6 & 12 months Post-operative)
研究者
Dr Prabhakar Kolamuri
Techsol Life Sciences Private Limited,