Visual Outcomes in Patients Contralaterally Implanted With PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 346
- 试验地点
- 9
- 主要终点
- Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters
研究概览
简要总结
Title:
Visual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
Sponsor:
Brian Shafer, MD, Shafer Vision Institute
Objective:
To compare visual outcomes and patient-reported satisfaction in cataract patients receiving either:
Contralateral implantation (PanOptix Pro in one eye, Clareon Vivity in the other)
Bilateral PanOptix Pro implants
Key hypotheses:
Contralateral implantation is non-inferior for binocular best-corrected distance visual acuity (BCDVA) at 4 m.
Contralateral implantation yields superior visual disturbance outcomes (less halo, glare, starburst).
Design:
Prospective, randomized, double-masked, two-arm, multicenter study
N = 346 subjects (173 per arm)
5 surgeons across 4 sites
All patients undergo bilateral phacoemulsification aiming for emmetropia
Randomized 1:1 to:
Arm 1: PanOptix Pro (dominant eye) + Clareon Vivity (non-dominant eye)
Arm 2: Bilateral PanOptix Pro
Surgical Details:
Femtosecond laser optional
Second eye surgery ≤4 weeks after first
Toric IOLs or arcuate incisions for residual astigmatism ≤0.50 D
Biometry with ARGOS, IOLMaster 700, or Lenstar
Toric alignment with ORA, Callisto, etc.
Assessments:
Visual acuity at 4 m, 66 cm, 40 cm, 33 cm in photopic and mesopic conditions
Defocus curves, contrast sensitivity (with/without glare)
Manifest refraction
Patient-reported outcomes via IOLSAT and QUVID questionnaires
Masking: subjects and assessors unaware of IOL assignments
Endpoints (at 3 months):
Primary: Binocular BCDVA (4 m)
Secondary: DCIVA, DCNVA, UDVA, UIVA, UNVA, defocus curves, refractive outcomes, visual disturbance scores
Exploratory: Mesopic VA, low contrast VA, contrast sensitivity, satisfaction scores
Eligibility Criteria:
Adults with bilateral age-related cataracts
Plan for bilateral phacoemulsification
Expected postop monocular BCDVA ≤0.1 logMAR (20/25)
Residual astigmatism ≤0.50 D
Exclusions include corneal pathology, macular disease, glaucoma, prior ocular surgery, amblyopia, severe dry eye, high HOA (>0.6 um), monovision preference, active infection/inflammation, pregnancy
Statistics:
Non-inferiority margin: 0.1 logMAR
Superiority testing for visual disturbances
Step-down testing hierarchy for primary and secondary outcomes
Sample size powered for 80% at α=0.05, accounting for 10% dropout
Two-proportion Z-tests for dysphotopsia rates
Safety Monitoring:
Adverse Events (AEs) and Serious Adverse Events (SAEs) captured
Definitions, severity grading, and reporting procedures specified
Protocol deviations documented and reported per IRB requirements
Data Handling:
Data anonymized via subject numbers
Stored securely (locked cabinets, password-protected systems)
Study registered at ClinicalTrials.gov
Visit Schedule:
Screening: Consent, eligibility, history
1st & 2nd Eye Surgery Visits
3-Month Post-Op Visit: Comprehensive visual assessments, questionnaires, AE review
详细描述
SVI-POPCV-001 Protocol Detailed Description
Title:
Visual Outcomes in Patients Contralaterally Implanted with PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
Sponsor and Investigator Brian Shafer, MD
Shafer Vision Institute, USA
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking: Double (Participant, Outcomes Assessor) Masking Description: Subjects and outcomes assessors will be blinded to IOL assignments to reduce bias in patient-reported outcomes and visual acuity testing. Surgeons are unmasked for implantation procedures but do not participate in postoperative assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years old) able and willing to provide informed consent.
- •Bilateral diagnosis of age-related cataracts.
- •Planned bilateral cataract removal by phacoemulsification with either:
- •Contralateral implantation of Clareon PanOptix Pro/PanOptix Pro Toric in one eye and Clareon Vivity/Vivity Toric in the fellow eye, or
- •Bilateral implantation of Clareon PanOptix Pro/PanOptix Pro Toric.
- •Expected best monocular corrected distance visual acuity (BCDVA) of 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively, as determined by the surgeon.
- •Residual astigmatism expected to be ≤0.50 diopters in both eyes postoperatively (using toric IOLs or arcuate incisions as needed).
- •Normal ocular findings aside from cataracts.
排除标准
- •Corneal pathology or irregular astigmatism.
- •Preexisting macular disease or other retinal degenerative disease expected to cause vision loss.
- •Severe dry eye disease.
- •Nystagmus or strabismus.
- •Zonular laxity or dehiscence, pseudoexfoliation.
- •Any condition (in the investigator's opinion) that may affect study endpoints.
- •Previous history of any ocular surgery, including corneal refractive surgery.
- •Subjects desiring monovision.
- •History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- •Total corneal higher-order aberrations (HOA) greater than 0.6 microns.
- •Any planned simultaneous or combined procedures at the time of cataract surgery (e.g., MIGS).
- •Participation in another clinical study that could interfere with study results.
- •Any active ocular infection or inflammation.
- •Pregnant, breastfeeding, or planning to become pregnant during the study (as determined by verbal inquiry).
结局指标
主要结局
Binocular Best-Corrected Distance Visual Acuity (BCDVA) at 4 meters
时间窗: 3 months post-operative visit
Binocular BCDVA measured in logMAR under photopic conditions (85 cd/m²) at 4 m using standardized ETDRS charts with the M\&S Clinical Trial Suite (CTS). Non-inferiority margin of 0.1 logMAR between treatment arms.
次要结局
未报告次要终点
研究者
Brian Shafer
Ophthalmologist
Shafer Vision Institute