Visual Outcomes of a New Monofocal Intraocular Lens With Modified Optical Profile: a Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Bino DCIVA
研究概览
简要总结
To evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (IOL) with two different monofocal IOLs in patients scheduled for bilateral cataract surgery.
详细描述
The main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of ICB00 IOL or ZCB00 IOL or CNA0T0 IOL respectively.
The ICB00 IOL is a modified monofocal IOL. Compared to other monofocal IOLs, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses.
Considering the modified optical profile of the ICB00 IOL, the primary objective will be the evaluation of visual performance at intermediate distance.
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
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically significant bilateral cataract (BCVA <20/40, cataract must be the primary cause of visual impairment)
- •axial length between 21 and 27 mm
- •the patient must be able to read, understand and provide written informed consent,
- •the patient must be willing and able to comply with all study and follow-up procedures
- •preoperative refractive cylinder ≤ 0.75 D
排除标准
- •anterior segment pathology that could significantly affect results (e.g., chronic uveitis, iritis, corneal dystrophy, keratoconus)
- •diabetic retinopathy
- •uncontrolled glaucoma and/or intraocular pressure IOP> 24 mmHg
- •all types of infections (acute eye disease, external/internal infection, systemic infection)
- •traumatic cataract
- •pupillary abnormalities including aniridia and/or pupil diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm
- •microphthalmia
- •amblyopia
- •degenerative visual disorders (for example macular degeneration, optic nerve atrophy or retinal disorders)
- •previous intraocular and corneal surgery
- •systemic or ocular pharmacotherapy, which may impact visual acuity and/or cause floppy iris syndrome and/or insufficient dilation in the opinion of the investigator
- •patients who are unable to fixate for a prolonged time (e.g. strabismus, nystagmus)
- •period of pregnancy or breastfeeding for female patients
结局指标
主要结局
Bino DCIVA
时间窗: 12 weeks after second eye surgery
Binocular distance corrected intermediate visual acuity
次要结局
- Bino UNVA(12 weeks after second eye surgery)
- Bino UIVA(12 weeks after second eye surgery)
- Mono BCDVA(12 weeks after second eye surgery)
- Mono DCIVA(12 weeks after second eye surgery)
- Catquest 9SF score changes(preop and 12 weeks after second eye surgery)
- Binocular defocus curves(12 weeks after second eye surgery)
- Bino BCDVA(12 weeks after second eye surgery)
- Mono UNVA(12 weeks after second eye surgery)
- Bino CNVA(12 weeks after second eye surgery)
- Mono UIVA(12 weeks after second eye surgery)
- Mono UDVA(12 weeks after second eye surgery)
- Bino UDVA(12 weeks after second eye surgery)
- Mono CNVA(12 weeks after second eye surgery)
研究者
Daniele Tognetto
Professor
University of Trieste