A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effective Lens Position（ELP）
研究概览
简要总结
To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients
详细描述
A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients.
The objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients.
PanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients over 18 years old
- •26 ≤Axial length<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D )
- •Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG)
- •Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA)
- •Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace);
- •Eyes with corneal spherical aberration ≤ 0.50 (Pentacam).
排除标准
- •Irregular corneal astigmatism
- •Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment
- •Moderate-severe dry eye, corneal scarring, amblyopia
- •Patients who can't cooperate with post-op 3 months follow-up.
研究组 & 干预措施
PanOptix
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
干预措施: PanOptix IOL implantation (Procedure)
结局指标
主要结局
Effective Lens Position（ELP）
时间窗: 3 months
Mean change of ELP for 3 months
次要结局
- Monocular distance corrected near visual acuity(DCNVA)(40cm)(3 months)
- capsule bending index（CBI）(3months)
- Monocular uncorrected distance visual acuity（UDVA）(3 months)
- Monocular uncorrected intermediate visual acuity（UIVA）(3 months)
- lOL tilt(3 months)
- lOL decentration(3 months)
- Monocular best corrected distance visual acuity（BCDVA）(5m)(3 months)
- Monocular uncorrected near visual acuity（UNVA）(3 months)
- modulation transfer function（MTF）(3 months)
- Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)(3 months)
- manifest refraction(3 months)
- high-order aberrations（HOA）(3 months)
- Monocular defocus curve(3 months)
研究者
Yune Zhao
Vice president of Eye Hospital of Wenzhou Medical University
Wenzhou Medical University