In Situ Analysis of the Optical Quality and Visual Solvency of Eyes Implanted Bilaterally With the Asqelio™ EDoF Toric Extended-focus Intraocular Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular dispersion index (OSI)
研究概览
简要总结
This study evaluates the optical quality and clinical performance of the Asqelio™ EDOF Toric intraocular lens (IOL) in patients undergoing cataract surgery or refractive lensectomy. The Asqelio™ EDOF Toric IOL aims to provide improved vision at various distances and correct astigmatism compared to monofocal IOLs. Postoperative outcomes, including visual clarity, refractive correction, and patient satisfaction, will be assessed three months after surgery.
详细描述
Cataract surgery is one of the most common procedures worldwide, typically involving the replacement of the cloudy natural lens with an intraocular lens (IOL). Traditional monofocal IOLs correct vision for a single distance but do not address intermediate or near vision, leading to dependence on glasses. The Asqelio™ EDOF Toric IOL is designed to provide extended depth of focus, smoother transitions across distances, and astigmatism correction, potentially enhancing overall visual quality and reducing the need for glasses.
This study compares the optical performance and patient outcomes of the Asqelio™ EDOF Toric IOL with those of monofocal IOLs. Key measures include optical quality, visual acuity at multiple distances, refractive correction, and patient-reported satisfaction. Results will be collected during a three-month postoperative follow-up. The findings aim to inform the effectiveness of the Asqelio™ EDOF Toric IOL in improving visual outcomes and quality of life for patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 years or older who have undergone cataract surgery with phacoemulsification or refractive lensectomy, with bilateral implantation of the Asqelio EDOF toric IOL model ETLIO130C/ETPIO130C with a cylinder value of 0.0 D, or the spherical monofocal J&J TECNIS 1-Piece IOL model ZCB
- •Patients who have signed the informed consent form.
- •Clear intraocular media, except for the presence of cataracts in both eyes prior to surgery.
- •Postoperative potential visual acuity of 20/25 or better
排除标准
- •Preoperative corneal astigmatism greater than 1.00D.
- •Patients who do not provide informed consent.
- •Patients who do not understand the study procedure.
- •Previous corneal surgery or trauma.
- •Irregular cornea (e.g., keratoconus).
- •Choroidal hemorrhage.
- •Microphthalmos.
- •Severe corneal dystrophy.
- •Uncontrolled or medically controlled glaucoma.
- •Clinically significant macular changes.
- •Severe concomitant ocular disease.
- •Cataract unrelated to aging.
- •Severe optic nerve atrophy.
- •Diabetic retinopathy.
- •Proliferative diabetic retinopathy.
- •Amblyopia.
- •Extremely shallow anterior chamber.
- •Severe chronic uveitis.
- •Pregnant or breastfeeding.
- •Mature/dense cataract preventing preoperative fundus examination.
- •Previous retinal detachment.
- •Concurrent participation in another drug or clinical device investigation.
- •Expectation of needing another ocular surgery during the study period
结局指标
主要结局
Ocular dispersion index (OSI)
时间窗: Three months after intraocular lens implantation
OSI value represents the ratio of the amount of light within an annular area of 12 to 20 arc minute and the light corresponding to a circular area of one minute of arc around the central peak. Determined using the OQAS II double pass system
Higher order aberrations Root Mean Square (HORMS)
时间窗: Three months after intraocular lens implantation
The RMS value for higher order aberrations is calculated from the wavefront error map, determined using Hartmann-Shack wavefront aberrometry. Measured in microns
Ocular Spherical Aberration
时间窗: Three months after intraocular lens implantation
Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns.
次要结局
- Monocular visual acuity for distance vision with correction (CDVA)(Three months after intraocular lens implantation)
- Monocular visual acuity for distance vision without correction (UDVA)(Three months after intraocular lens implantation)
- Monocular visual acuity for intermediate vision with correction for distance (DCIVA)(Three months after intraocular lens implantation)
- Monocular visual acuity for intermediate vision without correction (UIVA)(Three months after intraocular lens implantation)
- Monocular visual acuity for near vision with correction for distance (DCNVA)(Three months after intraocular lens implantation)
- Monocular visual acuity for near vision without correction (UNVA)(Three months after intraocular lens implantation)
- Postoperative refractive error(Three months after intraocular lens implantation)
- Monocular Contrast sensitivity(Three months after intraocular lens implantation)
- Binocular Contrast sensitivity(Three months after intraocular lens implantation)
- Defocus curve(Three months after intraocular lens implantation)
- CATQuest 9SF(Three months after surgery)
- Visual Symptoms questionnaire(Three months after surgery)