PureSee EDOF Versus ZCB00 Monofocal IOLs in Mild-to-Moderate Glaucoma
Clinical Outcomes, Contrast Sensitivity, and Patient Satisfaction Following Bilateral PureSee EDOF Versus ZCB00 Monofocal IOL Implantation in Patients With Mild to Moderate Primary Open-Angle Glaucoma: An Ambispective Investigator-Initiated Trial
This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery in patients with mild to moderate primary open-angle glaucoma (POAG). Two cohorts are compared: patients with bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (EDOF IOL) and patients with bilateral implantation of the TECNIS ZCB00 monofocal IOL.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Melissa Hamann Wright, Study Staff
- 电话号码:2389 713-580-2500
- 邮箱:Melissa.Wright@manneye.com
学习地点
-
-
Texas
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Houston、Texas、美国、77004
- Mann Eye Institute
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接触:
- Melissa Hamann Wright
- 电话号码:2389 713-580-2500
- 邮箱:Melissa.Wright@manneye.com
-
首席研究员:
- Phillip Brunson, OD
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients aged 45 years and older who underwent bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00, with bilateral mild or moderate primary open-angle glaucoma.
描述
Inclusion Criteria:
Age ≥45 years. Prior bilateral cataract surgery with bilateral implantation of either PureSee EDOF or TECNIS ZCB00 on or after March 12, 2026.
Intended postoperative refractive target between plano and -0.50 D in each eye. No intentional monovision. Bilateral mild or moderate POAG according to AAO ICD-10 staging criteria. Reliable glaucoma visual field available within approximately 18 months before cataract surgery or study enrollment, when available.
Reliable optical coherence tomography examination within 6 months. Adequately controlled IOP and clinically stable glaucoma in the investigator's opinion.
Prior SLT is permitted. Concurrent MIGS at the time of cataract surgery is permitted when clinically indicated at the discretion of the treating surgeon.
Ability to complete the study-specific examination and questionnaires. Study visit occurring 3-18 months following second-eye cataract surgery.
Exclusion Criteria:
Severe POAG or glaucomatous visual field loss involving fixation. Secondary glaucoma, including pseudoexfoliative, pigmentary, angle-closure, neovascular, or uveitic glaucoma.
Glaucoma surgery other than eligible concurrent MIGS that may materially influence study outcomes.
Corneal pathology or irregular astigmatism affecting visual outcomes. Prior corneal refractive surgery. Macular or neuro-ophthalmic disease affecting visual function. Other ocular pathology expected to limit postoperative CDVA to worse than 20/30.
Inability to obtain reliable visual field testing when required for glaucoma characterization.
Intentional monovision. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
PureSee EDOF IOL cohort
Subjects with bilateral implantation of the TECNIS PureSee Intraocular Lens (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS PureSee non-diffractive extended depth of focus intraocular lens (toric and non-toric) at cataract surgery. |
|
TECNIS ZCB00 monofocal IOL cohort
Subjects with bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
Bilateral implantation of the TECNIS Monofocal Intraocular Lens ZCB00 (toric and non-toric) at cataract surgery. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Distance visual acuity - binocular distance-corrected visual acuity (DCVA)
大体时间:3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected visual acuity measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intermediate visual acuity - binocular distance-corrected intermediate visual acuity (DCIVA)
大体时间:3 to 18 months following second-eye cataract surgery
|
Binocular distance-corrected intermediate visual acuity at 66 cm measured at the single study visit occurring 3 to 18 months following second-eye cataract surgery. |
3 to 18 months following second-eye cataract surgery
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Contrast sensitivity - binocular, distance-corrected, photopic CSV-1000 contrast sensitivity without glare
大体时间:3 to 18 months following second-eye cataract surgery
|
CSV-1000 contrast sensitivity at spatial frequencies of 3, 6, 12, and 18 cycles per degree, binocular, distance-corrected, photopic, without glare. |
3 to 18 months following second-eye cataract surgery
|
|
Spectacle independence at distance, intermediate, and near
大体时间:3 to 18 months following second-eye cataract surgery
|
Patient-reported spectacle independence at distance, intermediate, and near. |
3 to 18 months following second-eye cataract surgery
|
|
Quality of vision and dysphotopsias
大体时间:3 to 18 months following second-eye cataract surgery
|
Patient-reported quality of vision and dysphotopsias assessed with validated patient-reported outcome instruments including the AIOLIS Questionnaire. |
3 to 18 months following second-eye cataract surgery
|
|
Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionnaire
大体时间:3 to 18 months following second-eye cataract surgery
|
The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome. |
3 to 18 months following second-eye cataract surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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