Clinical Evaluation of Low Contrast Defocus Curves, Low Light Photic Phenomena, and Dysphotopsia Profiles in Pseudophakic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Low (50%) contrast defocus curve
研究概览
简要总结
The goal of this clinical investigation is to evaluate visual acuity and contrast sensitivity in low lighting conditions using several different testing devices, and measure nighttime side effects of intraocular lens (IOL) implants after cataract surgery.
Researchers will compare the results for three different types of IOLs to see how each lens contributes to overall visual function, patient experience and satisfaction.
Participants will:
- Complete two different questionnaires about their current vision
- Undergo visual testing using several different devices
详细描述
The purpose of the study is to correlate the low contrast defocus curves, objective halometry measurement of low light photic phenomena, and patient reported dysphotopsia profiles of the various study IOLs.
The primary endpoints are low (50%) contrast defocus curve, halometry (cool white light) assessment of photic phenomena, and PRVSQv2 results.
The secondary endpoints are:
- Visual Acuity
- BCDVA
- Low contrast (50%) BCDVA
- Contrast Sensitivity
- High contrast defocus curve
- Halometry:
- Light levels: low, medium, high
- Colors: cool white, warm white, red, green
- Characterization of glare, starbursts, and halos
- PRO questionnaires
- AIOLIS
- Patient satisfaction and recommendation survey
- Pupil size
- YAG capsulotomy within 1 year
- Posterior capsular opacification: pre-planned post-hoc analysis evaluating performance in patients w/wo PCO Monocular BCDVA
Participants will:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Minimum 22 years of age
- •Bilateral pseudophakia, at least 3 months postoperative from IOL implantation, with one of the study IOL models in at least one 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
- •Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils.
- •Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- •Uncorrected distance visual acuity worse than 20/25 in either eye
- •Prior corneal refractive surgery (LASIK, LASEK, RK, 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 are acceptable.
- •Posterior capsular opacification with grading worse than 1+
- •Ocular findings that may, in the opinion of the investigator, affect vision and/or contrast sensitivity
研究组 & 干预措施
Tecnis Monofocals
Pseudophakic subjects with Tecnis Monofocals, Models ZCB00, ZCUxxx, DIB00, GIB00, and DIUxxx intraocular lenses.
干预措施: None-placebo (Other)
Tecnis Symfony Optiblue
Pseudophakic subjects with Tecnis Symfony Optiblue, model ZXR00V, ZXWxxx intraocular lenses.
干预措施: None-placebo (Other)
Tecnis Odyssey
Pseudophakic subjects with Tecnis Odyssey, model DRN00V, DRTxxx intraocular lenses.
干预措施: None-placebo (Other)
结局指标
主要结局
Low (50%) contrast defocus curve
时间窗: Day 1
Measured low (50%) contrast defocus curve compared between all three groups
Halometry assessment of photic phenomena
时间窗: Day 1
Halometry assessment of halos and starbursts utilizing a cool white light with varying intensities. Comparing the measured size of the ring (deg) of each condition between all three groups.
PRVSQv2 questionnaire results
时间窗: Day 1
PRVSQv2 questionnaire results compared between all three groups: Frequency and bother/severity of symptoms (scale 1 to 5, with 5 most bothersome)
次要结局
- Best corrected distance visual acuity (BCDVA)(Day 1)
- Low contrast (50%) BCDVA(Day 1)
- Contrast Sensitivity(Day 1)
- High Contrast Defocus Curve(Day 1)
- Halometry(Day 1)
- Patient-Reported Outcome (PRO) Questionnaires(Day 1)
- Pupil Size(Day 1)
- YAG Capsulotomies(Day 1)
- Posterior capsular opacification (PCO)(Day 1)
研究者
Dr. Daniel H. Chang, MD
Principal Investigator
Empire Eye and Laser Center