A Non-Interventional Study to Evaluate the Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance in Patients Who Have Undergone Clareon® Vivity® IOL Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR)
研究概览
简要总结
The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.
The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?
Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:
- consent to participate in the study
- allow researchers to access their personal medical records
- undergo a series of tests to assess the position of their IOLs and quality of vision
Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.
详细描述
This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
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
- •Age ≥ 18 years
- •History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
- •Willing to undergo an eye exam with pupil dilation
排除标准
- •Moderate to severe posterior capsule opacification (2+ or more)
- •Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
- •Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
- •Any previous ocular surgery (excluding YAG, LASIK, PRK)
- •Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
- •Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)
- •Women who are pregnant at the time of screening (based on self-reported history)
- •Medical or other problems which in the opinion of the investigator will render study participation unsafe
结局指标
主要结局
Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR)
时间窗: Visit 1
CDVA100
时间窗: 1 Day
The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%).
IOL Decentration
时间窗: 1 day
The mean value and standard deviation of IOL decentration.
IOL Tilt
时间窗: 1 day
The mean value and standard deviation of IOL tilt.
次要结局
- Decentration of intraocular lens (IOL) (mm)(Visit 1)
- Tilt of intraocular lens (IOL) (°)(Visit 1)
- Monocular distance-corrected intermediate visual acuity (DCIVA) (66 cm) (logMAR)(Visit 1)
- Monocular uncorrected intermediate visual acuity (UCIVA) (66 cm) (logMAR)(Visit 1)
- Manifest refraction/Manifest refraction spherical equivalent (MRSE) (D)(Visit 1)
- Monocular uncorrected distance visual acuity (UCDVA) (4 m) (logMAR)(Visit 1)
- UCDVA100(1 day)
- UCIVA100(1 day)
- DCIVA100(1 day)
- MRSE(1 day)