NCT04619654已完成不适用
Visual Acuity, Refractive Predictability, and Patient Reported Quality of Vision in Subjects Implanted With a Trifocal IOL With Stable Mild Open-Angle Glaucoma Undergoing Concurrent Minimally Invasive Glaucoma Surgery
Vold Vision P.L.L.C2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
研究概览
简要总结
This study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 45 years of age or older
- •A visually significant cataract
- •Diagnosis of mild OAG
- •Vertical C/D ratio of less than or equal to 0.8
- •VF characteristics consistent with glaucoma with mean deviation not worse than -6.00 dB and without fixation threatening scotoma AND/OR with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc hemorrhage, nerve fiber layer loss)
- •Medicated IOP 25 of less than or equal to mmHg on 1-3 medications
- •If treatment naïve (before glaucoma treatment) IOP between 21 and 35 mmHg
- •Glaucoma must be judged as stable by investigator based on review of subject medical records
- •Stable VF at least 1 year prior to surgery
- •Stable nerve fiber layer at least 1 year prior to surgery
- •IOP stable on current medication regimen at least 3 months prior to surgery
- •Shaffer grade of greater than III in all quadrants
- •Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logMAR (20/25) postoperatively
- •Able and willing to comply with follow up visits
- •Understands and signs the informed consent
排除标准
- •Previous incisional glaucoma surgery or cilio-ablative surgery
- •Prior laser trabeculoplasty within 90 days of surgery
- •Pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma.
- •Moderate glaucoma with VF mean deviation between -6.00 dB and -12.00 dB
- •Severe and/or progressive glaucoma defined as
- •VF mean deviation worse than -12.00 dB
- •Consistent worsening of visual field on review of subject medical records
- •Consistent and progressive thinning of nerve fiber layer on review of subject medical records
- •Uncontrolled IOP on maximum glaucoma medications
- •Historically poor IOP control with medical therapy
- •Severe focal notching of the optic nerve rim
- •Expectation for future need of incisional glaucoma surgery
- •Ocular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study period.
- •Ocular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e. significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history of significant ocular trauma with sequela, etc.
- •Pregnant or breastfeeding women
- •Prior refractive surgery e.g. LASIK, RK, PRK, etc.
结局指标
主要结局
Mean Photopic Monocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR
时间窗: 3 months
次要结局
- Mean Photopic Binocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR(3 months)
- Mean Photopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar(3 months)
- Mean Photopic Monocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR(3 months)
- Mean Photopic Monocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR(3 months)
- Mean Photopic Monocular Best Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) logMAR(3 months)
- Mean Photopic Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR(3 months)
- Mean Photopic Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm) logMAR(3 months)
- Mean Photopic Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR(3 months)
- Mean Photopic Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm) logMAR(3 months)
- Mean Photopic Binocular Best Corrected Distance Visual Acuity (DCVA) (4 meters) logMAR(3 months)
- Mean Photopic Binocular Best Distance Corrected Near Visual Acuity (DCNVA) (40 cm) logMAR(3 months)
- Mean Photopic Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 meters) logMAR(3 months)
- Mean Mesopic Binocular Best Corrected Distance Low Contrast Visual Acuity (25%) (4 meters) logMar(3 months)
研究者
研究点 (2)
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