Clinical Evaluation of Violet Light Filtration and High-resolution Lathing on a Diffractive Extended Depth of Focus Intraocular Lens (IOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient reported nighttime dysphotopsia symptoms
研究概览
简要总结
The goal of this clinical study is to compare the Tecnis Symfony Optiblue intraocular lens implant to the Tecnis Symfony intraocular lens implant in patients over 22 years old with cataracts in both eyes. The main questions it aims to answer are:
Which lens has less nighttime side effects? Which lens has higher patient satisfaction?
Participants will undergo a minimum of 7 study visits where they will complete a variety of vision tests and vision questionnaires.
详细描述
This is 6 month, prospective, single center, subject/evaluator masked, bilateral, randomized clinical investigation of the TECNIS Symfony Model ZXR00V/ ZXW150 IOLs versus the TECNIS Symfony Model ZXR00/ZXT150 control IOL.
The study will enroll approximately 60 subjects to achieve approximately 54 randomized and bilaterally implanted subjects, resulting in approximately 25 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZXR00V/ZXW150 or the ZXR00/ ZXT150 control IOL. The eye implanted first will be considered the primary study eye.
Surgeons will perform routine, small-incision cataract surgery and implant the study lenses using an implantation system qualified by the respective manufacturer for use with that IOL. The target for refractive outcomes will be emmetropia for both eyes.
All subjects will undergo a minimum of 7 study visits: Preoperative for both eyes; Operative for each eye; 1 week first eye and second eye, 1 month and 6 month visits for both eyes together.
The primary endpoint is patient reported nighttime dysphotopsia symptoms as measured by the PRVSQ v2 questionnaire.
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, Care Provider)
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
- •All criteria apply to each study eye
- •Minimum 22 years of age
- •Bilateral cataracts for which posterior chamber IOL implantation has been planned
- •Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with a glare source or 20/40 Snellen or worse without a glare source
- •Potential for postoperative BCDVA of 20/30 Snellen or better
- •Corneal astigmatism:
- •Normal corneal topography
- •Preoperative corneal astigmatism range from 0 D - 2.0 D
- •Clear intraocular media other than cataract in each eye
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
- •Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
- •Ability to understand and respond to a questionnaire in English
排除标准
- •All criteria apply to each study eye:
- •Requiring an intraocular lens power outside the available range of power
- •Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- •Irregular corneal astigmatism
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •Prior corneal refractive surgery (LASIK, LASEK, radial keratotomy (RK), photorefractive keratectomy (PRK), etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcomes or increase risk to the subject, are acceptable.
- •Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
- •Inability to achieve keratometric stability for contact lens wearers
- •Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- •Subject with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
- •Use of systemic or ocular medications that may affect vision
- •Prior, current, or anticipated use during the course of the 6 month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
- •Poorly controlled diabetes
- •Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
- •Known ocular disease or pathology that, in the opinion of the investigator,
- •may affect visual acuity
- •may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
- •may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- •Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
- •Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
- •Desire for monovision correction
结局指标
主要结局
Patient reported nighttime dysphotopsia symptoms
时间窗: Pre-op visit, 1 month post-op visit, 6 month post-op visit
Patient-Reported Visual Symptoms Questionnaire (PRVSQ)
次要结局
- Low contrast visual acuity with glare(1 month post-op visit, 6 month post-op visit)
- Patient overall satisfaction(1 month post-op visit, 6 month post-op visit)
研究者
Dr. Daniel H. Chang, MD
Principal Investigator
Empire Eye and Laser Center