BMVDI Study: Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus IOL
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular lens (IOL).
Clareon TruPlus IOL is designed to provide an extended range of vision compared to the parent monofocal IOL. Clareon TruPlus IOL delivers excellent intermediate vision without compromising distance vision including the quality of vision with low incidence of visual disturbances in normal cataract patients.
Binocular distance-corrected intermediate visual acuity at 66cm will be assessed at a pre-specified postoperative interval 12 weeks after second eye surgery. This study hypothesizes that Clareon TruPlus IOL delivers good binocular DCIVA at 66cm 12 weeks after second eye surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to understand and sign informed consent.
- •Able and willing to complete all required study visits.
- •Diagnosed with age-related cataracts in both eyes (OU)
- •Bilateral age-related cataract scheduled for phacoemulsification in both eyes by a single surgeon.
- •Surgeon predicts postoperative best corrected distance visual acuity (BCDVA) of ≥ 20/25 or better with Manifest Refractive Spherical Equivalent (MRSE) ±0.50 D of plano and in each eye post-operatively.
- •Clear intraocular media aside from cataract.
- •Will receive TruPlus bilaterally
- •Postoperative residual astigmatism ≤ 0.75 D in both eyes.
- •Refractive target: Emmetropia OU
- •Patient groups agreeing to either Femtosecond Laser Assisted Cataract Surgery (FLACS) or Standard phaco
排除标准
- •Ocular comorbidities affecting visual outcomes, including but not limited to:
- •Macular disease (e.g., Age-Related Macular Degeneration [AMD], Diabetic Macular Edema [DME], Epiretinal Membrane [ERM]).
- •Active ocular inflammation.
- •Any investigator-determined condition likely to confound postoperative visual performance.
- •Strabismus with or without amblyopia in either eye.
- •Prior anterior or posterior segment surgery, including corneal refractive procedures.
- •History of retinal detachment.
- •Degenerative retinal or visual disorders deemed clinically significant by the investigator.
- •Diagnosed glaucoma (of any stage, if deemed vision-impacting by investigator).
- •Systemic conditions that could affect healing or study outcomes (e.g., immunocompromised, connective tissue disease, clinically significant atopy, diabetes).
研究者
Ganesha Kandavel
Principal Investigator
Colvard Kandavel Eye Center