Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 5
- 主要终点
- Binocular DCNVA
研究概览
简要总结
The purpose of this study is to evaluate the AcrySof PanOptix Intraocular Lens (IOL) for binocular distance corrected near visual acuity (DCNVA) compared to TECNIS Synergy IOL.
Presbyopia correcting diffractive intraocular implants (extended depth of focus, multifocal, and trifocal) provide cataract and refractive surgeons with an effective treatment means for allowing patients to experience increased spectacle independence post-cataract surgery.
详细描述
Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses.
Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Note: Ocular criteria must be met in both eyes.
- •are willing and able to understand and sign an informed consent;
- •are willing and able to attend all study visits;
- •Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted
- •Clear intraocular media other than cataracts.
- •Projected BCDVA of better than 0.10 logMAR.
- •Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes
- •Biometer IOL calculations within +6.0 - +30.0 power range
排除标准
- •If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- •Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity
- •Glaucoma or Ocular Hypertension
- •Planned multiple procedures (eg MIGS)
- •Amblyopia, Strabismus
- •Patient's IOL calculation that are outside the range of available lenses
- •Prior corneal refractive surgery or other corneal surgery (e.g., corneal transplant, lamellar keratoplasty, LASIK, PRK)
- •Previous anterior or posterior chamber surgery (e.g., vitrectomy) that the investigator feels may compromise visual outcomes
- •Diabetic retinopathy if the investigator feels this will compromise visual outcomes
- •Macular Pathology (i.e., ERM, ARMD, DMR etc.) if the investigator feels this will compromise visual outcomes
- •History of retinal detachment
- •If, in the surgeon's opinion, the subject is not an appropriate candidate for multifocal IOL implantation (eg. patients who are professional night drivers or pilots, and those with other occupations for whom induces dysphotopsias could put their career at risk)
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.
研究组 & 干预措施
AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)
The subject will be implanted bilaterally during cataract surgery
干预措施: AcrySof® IQ PanOptix® (Device)
AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)
The subject will be implanted bilaterally during cataract surgery
干预措施: Cataract Surgery (Procedure)
Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)
The subject will be implanted bilaterally during cataract surgery
干预措施: Synergy® (Device)
Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)
The subject will be implanted bilaterally during cataract surgery
干预措施: Cataract Surgery (Procedure)
结局指标
主要结局
Binocular DCNVA
时间窗: Up to Month 6
Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
次要结局
- Visual Disturbances Evaluation by Questionnaire (QUVID)(Up to Month 6)
- BCDVA and DCIVA (60 cm)(Up to Month 6)
- DCNVA (40 cm)(Up to Month 6)
- Visual Disturbances Evaluation(at all visits)
- Uncorrected Monocular and Binocular VA(Up to Month 6)
- Defocus Curve(Up to Month 6)
- Visual Disturbances Evaluation by Questionnaire (IOL SAT)(Up to Month 6)