Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset
研究概览
简要总结
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
详细描述
This is a non-interventional prospective, comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU***) or Clareon IOL (CNA0T0) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to compare distance and intermediate visual acuities and a defocus curve in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
Patients will be assessed for corrected binocular distance and intermediate vision.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes.
- •Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU***).
- •Able to comprehend and willing to sign informed consent and complete all required testing procedures
- •Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
- •Clear intraocular media
- •Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO
排除标准
- •Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
- •Any complication during cataract surgery (capsular tear, vitrectomy, etc)
- •History of or current retinal conditions in either eye that would confound the results of this investigation in the opinion of the investigator (e.g. retinal detachment, epiretinal membrane, retinal ischemia, retinal inflammation, etc)
- •Amblyopia or strabismus in either eye
- •History of or current anterior or posterior segment inflammation of any etiology
- •Any form of neovascularization on or within the eye
- •Glaucoma (uncontrolled or controlled with medication)
- •Optic nerve atrophy
- •Subjects with diagnosed degenerative eye disorders
- •Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye.
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
结局指标
主要结局
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset
时间窗: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity
时间窗: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Distance corrected binocular intermediate visual acuity (measured at 66 cm) of Clareon subjects versus Eyhance subjects with both groups set at plano sphere. Non-inferiority defined as 1 line.
Non-inferiority of Best Corrected Distance Visual Acuity
时间窗: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.
Binocular Distance Corrected Defocus Curve
时间窗: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
The Binocular Distance Corrected Defocus Curve measures visual acuity across simulated distances (+1.0D to -3.0D) in subjects with intraocular lenses (IOLs) post-cataract surgery. Testing begins with the best corrected visual acuity (BCVA), and the patient's refractive error is entered into the phoropter as the 0 position. Defocus lenses are introduced in 0.5D increments to simulate various distances. Visual acuity is measured binocularly at each level using standardized charts (e.g., ETDRS, Snellen) and recorded in logMAR. Measurements are taken at least 3 months post-op under standardized lighting conditions to evaluate visual performance across the defocus range in IOL patients.
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset
时间窗: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
次要结局
- Postoperative Residual Astigmatism(Minimum of 3 months post-operatively from cataract surgery, up to 2 years)
- Post-operative Spherical Equivalent(Minimum of 3 months post-operatively from cataract surgery, up to 2 years)