A Randomized Controlled Trial on the Visual Function After Bilateral Implantation of Two Novel Extended Depth-of-Focus Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Binocular uncorrected intermediate visual acuity
研究概览
简要总结
Since intermediate vision is becoming increasingly important in our day-to-day tasks, a new IOL was introduced (Acunex Vario) with this objective in mind. This IOL provides excellent vision at far and intermediate distances up to 60 cm and with negligible photopic disturbances compared to conventional multifocal lenses. The Alcon AcrySof IQ Vivity IOL is designed to provide continuous vision from distance to intermediate while preserving contrast sensitivity and with a monofocal visual disturbance profile. So far, there are no published studies comparing these new IOL designs that offer an extended range of vision at far and intermediate distances.
Objective: The primary objective of this study is to compare the binocular uncorrected intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Vario IOL versus those bilaterally implanted with the Vivity IOL.
Study design: controlled double masked, randomized, prospective clinical trial Study population: patients of 18 years or older with bilateral cataracts that require cataract surgery.
Intervention: One group receives bilateral implantation with the Vario IOL and the other group receives bilateral implantation with the Vivity IOL.
Main study parameters: The main study parameter is the binocular UIVA at 66 cm under photopic conditions at 3 months postoperatively.
Hypothesis: The investigators hypothesise that bilateral implantation with the Vario IOL is non-inferior when compared to bilateral implantation with the Vivity IOL, with regards to binocular UIVA at 66 cm under photopic conditions 3 months postoperatively.
Cataract extraction in this study will proceed according to regular cataract surgery. As with any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug reactions, and surgical problems. Postoperatively, there will be one extra postoperative visit, compared to standard cataract surgery follow-up. Spectacle-independency postoperatively, without photopic phenomena, is one of the major expected benefits when treating cataract (and presbyopia) with the implantation of the Vario or Vivity IOLs.
详细描述
INTRODUCTION AND RATIONALE
Nowadays, the most common types of intraocular lenses (IOLs) to correct aphakia after cataract surgery consist of monofocal, multifocal or extended depth of focus (EDOF) IOLs.
Current monofocal IOLs provide one focal point which will provide the patient with unaided vision at only one distance, which necessitate the need of glasses to correct vision at all other distances.
Multifocal IOLs (mIOLs) can be divided into bifocal-, trifocal- or quadrifocal IOLs, and provide patients with unaided vision at more than one distance, causing less spectacle-dependency after cataract surgery. Although mIOLs offer better unaided near vision and less spectacle dependency in comparison to monofocal IOLs, a well-known drawback of mIOLs is the occurrence of halos and glare and the inherent loss of contrast sensitivity because of their optical design. The potential decrease in quality of vision makes implantation of mIOLs less suitable in highly demanding patients or in cases of pre-existing pathology of the visual pathway (i.e., macular degeneration, optic neuropathy, post refractive surgery).
EDOF IOLs offer an extended range of focus and enable the patient to have a wider range of unaided vision in comparison to monofocal IOLs, especially from intermediate to far, while mIOLs have shown better near vision in comparison to EDOF IOLs.
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 (Participant)
盲法说明
Study optometrists (who will perform the examinations)
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
- •Minimum 18 years of age
- •Bilateral cataract
- •Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ Vivity® IOL
- •Expected postoperative astigmatism ≤ 1.00 D (use of femtosecond laser assisted cataract surgery (FLACS) AK's tolerated up to 1.5 D of corneal astigmatism preoperative)
- •Bilateral implantation of a non-toric Acunex® Vario IOL or a non-toric Alcon AcrySof® IQ Vivity® IOL
- •IOL power calculation between +10.00 D and +30.0 D
- •Expected postoperative best-corrected visual acuity of logMAR 0.3 or better
- •Availability to undergo second eye surgery on the same day or else 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
- •Corneal pathology (i.e., fuchs endothelial dystrophy (FED), irregular astigmatism, herpes simplex virus (HSV) keratitis
- •Extensive age-related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen) and post-intravitreal injection (IVI)
- •Extensive visual field loss (eg. glaucoma, cerebral vascular accident (CVA), hemianopsia, etc.)
- •Extensive diabetic retinopathy
- •Amblyopia, strabismus, diplopia
- •Pseudo exfoliation 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, stroke, etc.)
- •Suturing of incision required at time of surgery
- •Complications during surgery of the first eye.
研究组 & 干预措施
Vario-group
Patients in this group recieve the Acunex Vario IOL bilaterally during the cataract surgery.
干预措施: Acunex Vario intraocular lens (Device)
Vivity-group
Patients in this group recieve the Alcon Acrysof IQ Vivity IOL bilaterally during the cataract surgery.
干预措施: Alcon AcrySof IQ Vivity intraocular lens (Device)
结局指标
主要结局
Binocular uncorrected intermediate visual acuity
时间窗: 3 months postoperatively
The visual acuity will be measured at 66cm under photopic conditions
次要结局
- Mono- and binocular uncorrected and corrected distance visual acuity(At week 1, 1 month and 3 months postoperatively)
- Questionnaires on the bothersome of optical complaints(At 3 months postoperatively)
- Mean binocular constrast sensitivity(At 3 months postoperatively)
- Questionnaires on patient difficulty rate(Preoperatively and at 3 months postoperatively)
- Questionnaires on spectacle independence(At 3 months postoperatively)
- Mean binocular distance-corrected intermediate visual acuity(At 1 and 3 months postoperatively)
- Questionnaires on patient satisfaction rate(Preoperatively and at 3 months postoperatively)
- Questionnaires on occurence of optical complaints(At 3 months postoperatively)
- Complication profile including halos and glare(Up to 3 months postoperatively)
- Binocular defocus curves(At 3 months postoperatively)
- Tilt and decentration intraocular lens(At 1 month postoperatively)
- Mean binocular uncorrected near visual acuity and distaqnce corrected near visual acuity(At 1 and 3 months postoperatively)