A Randomised, Subject-masked Evaluation of Visual Function After Bilateral Implantation of Two Types of Presbyopia-correcting IOLs: the Symfony-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions.
研究概览
简要总结
Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.
The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.
详细描述
Rationale: Since the introduction of intraocular lenses (IOL) in the treatment of cataract, the postoperative accommodative loss of the human eye has been a trending topic. Numerous studies show a high rate of spectacle-independency after bilateral implantation of multifocal IOLs (MIOL). However, glare, halos, and reduced visual acuity under different light conditions are common complaints after MIOL implantation. Due to its unique design, the TECNIS® Symfony Extended Range of Vision ZXR00 IOL (Abbott Medical Optics, Santa Ana, USA, hereinafter referred to as Symfony IOL) is theoretically providing a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs under different light conditions.
The goal of this study is to compare the AT LISA tri 839MP IOL (Carl Zeiss Meditec AG, Jena, Germany, hereinafter referred to as AT LISA IOL) versus the Symfony IOL in terms of postoperative achieved visual acuity at different distances, patient satisfaction (e.g. spectacle-independency, QoL), and postoperative complication profile (e.g. halo's and glare) under different light conditions. So far, there are no published studies comparing both IOLs. Therefore, we will perform this randomized control trial.
Objective: The primary objective of this study is to compare the postoperative visual outcomes in a series of patients bilaterally implanted with the AT LISA IOL versus those bilaterally implanted with the Symfony IOL.
Study design: Single-centre randomised clinical trial. Study population: 30 patients (60 eyes) with bilateral cataract who require cataract surgery.
Intervention (if applicable): Cataract surgery with bilateral implantation of either a Symfony IOL or an AT LISA IOL.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum 21 years of age
- •Bilateral cataract
- •Bilateral implantation of Tecnis Symfony IOL or AT LISA IOL (same lens model in both eyes)
- •Expected postoperative astigmatism ≤ 1.00 D (combination with FLACS AK is tolerated up to 1.5 D preoperative astigmatism)
- •IOL power calculation between +10.00 D and 32.00 D
- •Expected postoperative best-corrected visual acuity of logMAR +0.3 or better
- •Availability to undergo second eye surgery within 2 weeks of the first eye surgery
- •Willing and able to comply with scheduled visits and other study procedures
- •Signed informed consent.
排除标准
- •Previous corneal surgery and/or reshaping
- •Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- •Irregular astigmatism
- •Keratoconus
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •Extensive age related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen)
- •Extensive visual field loss (e.g., glaucoma, history of cerebral vascular accidents, etc.)
- •Extensive diabetic macular disease
- •History of amblyopia and/or strabismus
- •Pseudoexfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- •Cognitive, cerebral or concentration disorders (e.g. dementia, Parkinson, history of CVA, etc.)
- •Suturing of incision required at time of surgery
- •Complications during surgery of the first eye.
研究组 & 干预措施
SYMFONY IOL
The unique design of this IOL merges two complementary enabling technologies: (1) its diffractive echelette design feature extends the range of vision, and (2) achromatic technology corrects chromatic aberration for enhanced contrast sensitivity. Theoretically, combining these two mechanism of action results in a continuous range of high-quality vision for far, intermediate, and near distances with the same low incidence of halos and glare associated with monofocal IOLs (see figure 2).
Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag.
干预措施: SYMFONY IOL (Device)
AT LISA tri 839MP IOL
This trifocal IOL provides three useful focal distances, far, intermediate, and near, and therefore aims to provide functional visual restoration after cataract surgery.
Primary indication is implantation for the visual correction in adult patients in whom a cataractous lens has been removed, who desire useful vision over a continuous range of distances including far, intermediate, and near, resulting in spectacle independency. This device is intended to be placed in the capsular bag.
干预措施: AT LISA tri 839MP IOL (Device)
结局指标
主要结局
Binocular uncorrected intermediate (66cm) visual acuity under both photopic and mesopic conditions.
时间窗: 3 months / 13 weeks
The mean binocular uncorrected intermediate visual acuity at 66 cm under both photopic and mesopic conditions at 13 weeks (3 months) postoperatively
次要结局
- Contrast sensitivity(3 months/13 weeks)
- Binocular visual acuity(3 months / 13 weeks)
- Quality of Life(pre-op and 3 months/13 weeks)