Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 461
- 试验地点
- 1
- 主要终点
- Distant corrected intermediate visual acuity
研究概览
简要总结
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
outcome assessor will be masked to the intraocular lens implanted
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
- •Age 50 to 100
- •Visual potential in both eyes of 20/25 or better as determined by investigators estimation
- •Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)
- •postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X))
- •Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))
排除标准
- •Preceding intraocular surgery or ocular trauma
- •Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
- •Pupil diameter < 2.0 mm (photopic)
- •Laser treatment
- •Uncontrolled systemic or ocular disease
- •Pregnancy/Nursing
- •childbearing ability
研究组 & 干预措施
Monofocal IOL I vs. enhanced monofocal IOL I
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Monofocal IOL II vs. enhanced monofocal IOL I
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Monofocal IOL III vs. enhanced monofocal IOL II
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Enhanced monofocal IOL II vs. enhanced monofocal IOL II
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Monofocal IOL IV vs. enhanced monofocal IOL III
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatism
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm six (VI) participants will receive an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed.
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Extended Depth of Focus IOL in eyes with irregular astigmatism
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm seven (VII) participants will receive an extended depth of focus IOL (IC-8 Apthera IOL) in one eye if irregular astigmatism is observed.
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Monofocal IOL IV vs. enhanced monofocal IOL IV
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm eight (VIII) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire)
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Enhanced depth of focus IOL I vs. Enhanced depth of focus IOL I
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm nine (IX) participants will receive an enhanced depth of focus IOL (PureSee) bilateral with a monovision target.
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
Monofocal IOL VI and monofocal IOL III
The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm ten (X) participants will receive a monofocal IOL (Vivinex XC1) bilateral or a monofocal IOL (Vivinex XY1) bilateral.
干预措施: phacoemulsification and intraocular lens implantation (Procedure)
结局指标
主要结局
Distant corrected intermediate visual acuity
时间窗: 2-6 months
Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL
时间窗: 3-5 months
Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Distant corrected intermediate visual acuity
时间窗: 2-6 months
Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL
时间窗: 3-5 months
Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.
Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1
时间窗: 2-6 months and 1-5 years
Primary outcome measures for arm ten (X) will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions
次要结局
- Contrast sensitivity and reading ability(2-6 months and 1-5 years)
研究者
Christina Leydolt
Assoc. Prof. PD Dr
Medical University of Vienna