NCT06229106已完成4 期
Evaluation of the Symfony With Optiblue Intraocular Lens Compared to The Vivity IOL Under Mesopic Conditions
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.
研究概览
简要总结
The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU.
- •Gender: Males and Females.
- •Age: 50 years and older.
- •Willing and able to provide written informed consent for participation in the study
- •Willing and able to comply with scheduled visits and other study procedures.
- •Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries.
- •Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
排除标准
- •Severe preoperative ocular pathology
- •Uncontrolled diabetes.
- •Use of any systemic or topical drug known to interfere with visual performance.
- •Contact lens use during the active treatment portion of the trial.
- •Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.
- •Clinically significant corneal dystrophy.
- •Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.
- •History of chronic intraocular inflammation.
- •History of retinal detachment.
- •Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- •Previous intraocular surgery.
- •Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
- •Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)
- •Previous keratoplasty
- •Severe dry eye
- •Pupil abnormalities
- •Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK)
- •Any clinically significant, serious, or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- •Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
结局指标
主要结局
Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.
时间窗: 3 months after surgery
logMAR visual acuity
次要结局
- Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.(3 months after surgery)
- Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions(3 months after surgery)
研究者
研究点 (4)
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