Assessment of Tolerance and Visual Outcomes After Bilateral Implantation of a Premium Type Intraocular Lens (Acrysof IQ Vivity IOL) in Patients With Cataract and Mild Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Distance-Corrected Visual Acuity in the Dominant Eye
研究概览
简要总结
The goal of this clinical trial is to learn if the Vivity Extended Depth of Focus intraocular lens works to improve vision in adults with cataracts and early-stage keratoconus. It will also learn about the safety and tolerance of this premium lens in patients with mild corneal irregularities. The main questions it aims to answer are:
- Does the Vivity EDOF lens provide good distance vision (20/25 or better) in the dominant eye at 3 months after surgery?
- Does it improve vision at intermediate and near distances compared to before surgery?
- Does it preserve contrast sensitivity and optical quality despite mild corneal irregularities?
- What is the patient-reported quality of life and satisfaction after implantation?
- What visual disturbances (such as halos) do participants experience?
All participants will:
- Receive the Vivity EDOF intraocular lens (or its toric version if astigmatism is present) in both eyes during standard cataract surgery, with the second eye operated within 7 days;
- Undergo comprehensive eye examinations before surgery including vision testing, corneal imaging, and optical quality measurements;
- Attend a follow-up visit at 3 months after surgery for detailed vision testing at multiple distances, contrast sensitivity testing under different lighting conditions, halo assessment, and quality-of-life questionnaires.
详细描述
Background and Rationale Keratoconus (KC) is a progressive, non-inflammatory corneal ectasia characterized by stromal thinning and irregular astigmatism, often resulting in significant higher-order aberrations (HOAs) that impair visual quality. Due to these optical limitations, the use of premium intraocular lenses (pIOLs) has traditionally been considered contraindicated in these patients. However, in patients with early-stage keratoconus, corneal shape and optical quality can be relatively well preserved, with HOAs remaining within acceptable limits. These patients may thus benefit from carefully selected premium IOL technologies.
Extended-depth-of-focus (EDOF) IOLs, in contrast to traditional multifocal lenses, not only provide significantly fewer visual disturbances but, thanks to their elongated focus, they could mitigate HOAs and coma-like distortions characteristic of early keratoconus. Unlike monofocal or multifocal lenses, which rely on a single, sharp focal point or discrete focal planes, EDOF lenses are inherently designed to maintain functional retinal image quality across an extended focal range, offering greater tolerance to minor defocus and wavefront aberrations. While EDOF lenses do not correct such aberrations, their extended focal range may reduce the impact of this distortion on functional vision. This is especially true for non-diffractive EDOF lenses, which preserve high levels of contrast sensitivity by not splitting light energy into multiple focal points.
The AcrySof IQ Vivity IOL (Alcon, Fort Worth, TX, USA) is a non-diffractive EDOF IOL that uses wavefront-shaping technology to elongate the focal range. Previous studies have already demonstrated good outcomes in patients with other challenging ocular conditions such as glaucoma, macular degeneration, and epiretinal membrane. The present pilot study aims to evaluate the visual performance, tolerance, and optical quality outcomes following implantation of the Vivity IOL in patients with cataract and stable, early-stage keratoconus. This investigation explores the clinical viability of premium IOLs in a population traditionally excluded from such refractive options.
Study Design This is a prospective, interventional, single-center pilot study conducted in Italy. The study has been approved by the local ethics committee (protocol number 22546) and adheres to the principles of the Declaration of Helsinki. A total of 10 patients (20 eyes) with cataracts and mild bilateral keratoconus will be enrolled and followed for 3 months after bilateral implantation of the AcrySof IQ Vivity EDOF IOL.
Study Objectives
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
- •Adults requiring bilateral cataract surgery
- •Mild bilateral keratoconus defined as stage 0-1 according to the ABCD classification system
- •Keratoconus stability defined as maximum keratometry (K) changes less than 1 diopter and maximum pachymetry reduction less than 2% within the previous 5 years
- •Pre-cataract spectacle distance-corrected visual acuity of 0.1 to 0.0 LogMAR (Snellen 20/25 to 20/20)
- •Agreement to bilateral implantation of AcrySof IQ Vivity Extended Depth of Focus intraocular lens
- •Willingness to undergo second-eye surgery within 7 days after first-eye procedure
- •Ability and willingness to attend all scheduled follow-up visits as per study protocol
- •Provision of written informed consent to participate in the study
排除标准
- •Any ocular comorbidities other than cataract and keratoconus, or history of any disease that could affect visual results (e.g., glaucoma, retinal disorders)
- •Corneal opacity including any corneal scarring
- •Advanced or progressive keratoconus
- •Any previous ocular surgery other than corneal cross-linking performed at least 5 years prior to enrollment
- •Corneal cross-linking performed within 5 years prior to enrollment
- •Amblyopia
- •Pseudoexfoliation syndrome or zonular laxity
- •History of uveitis
研究组 & 干预措施
Vivity EDOF IOL in Early Keratoconus
Adults with cataracts and mild, stable bilateral keratoconus (ABCD stage 0-1) undergo bilateral implantation of the AcrySof IQ Vivity Extended Depth of Focus (EDOF) intraocular lens during standard phacoemulsification cataract surgery. The toric version is used in eyes with regular corneal astigmatism ≥1.00 D. Surgery is performed under topical anesthesia by the same surgeon, targeting bilateral emmetropia using Kane formula for IOL power calculation. The second eye is operated within 7 days of the first. The Vivity IOL is a non-diffractive EDOF lens utilizing X-WAVE wavefront-shaping technology to extend focal range without splitting light, designed to reduce visual disturbances while providing functional vision at distance, intermediate (66 cm), and near (40 cm). Comprehensive visual, optical quality, contrast sensitivity, and patient-reported outcomes are assessed at 3 months postoperatively
干预措施: Extended Depth of Focus Intraocular Lens Implantation (Device)
结局指标
主要结局
Distance-Corrected Visual Acuity in the Dominant Eye
时间窗: 3 months after surgery
Monocular distance-corrected visual acuity (DCVA) measured in the dominant eye at 4 meters using CSO Vision Charts software version 14.0, recorded in logMAR units. Lower logMAR values indicate better visual acuity (e.g., 0.0 logMAR = Snellen 20/20; 0.1 logMAR = Snellen 20/25). Visual acuity is measured with best spectacle correction to assess the maximum visual performance achievable with the implanted IOL. The target outcome is DCVA of 0.1 logMAR (20/25) or better, indicating clinically excellent visual function. This primary endpoint evaluates whether the Vivity EDOF IOL can maintain high-quality distance vision despite the presence of mild corneal irregularities characteristic of early keratoconus
次要结局
- Monocular and Binocular Uncorrected Distance Visual Acuity(Baseline (preoperative) and 3 months after surgery)
- Monocular and Binocular Uncorrected and Distance-Corrected Near Visual Acuity(Baseline (preoperative) and 3 months after surgery)
- Monocular and Binocular Uncorrected and Distance-Corrected Intermediate Visual Acuity(3 months after surgery)
- Binocular Defocus Curve Visual Acuity Profile(3 months after surgery)
- Monocular and Binocular Contrast Sensitivity Under Photopic, Mesopic, and Scotopic Conditions(3 months after surgery)
- Total Root Mean Square (RMS) Wavefront Error(3 months after surgery)
- Root Mean Square Wavefront Error at 3 mm and 4 mm Pupil Diameters(3 months after surgery)
- Point Spread Function Strehl Ratio at 3 mm and 4 mm Pupil Diameters(3 months after surgery)
- Binocular Halo Perception Using Aston Halometer(3 months after surgery)
- NEI-RQL-42 Quality of Life Scores(3 months after surgery)
- Incidence of Intraoperative and Postoperative Adverse Events(From surgery through 3 months postoperatively)
研究者
Emilio Pedrotti
Full Professor in Ophthalmology
Azienda Ospedaliera Universitaria Integrata Verona