Visual and Patient-Reported Outcomes Following Bilateral Implantation of Non-Diffractive Extended Depth-of-Focus Intraocular Lenses in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Binocular Uncorrected Distance Visual Acuity (UDVA)
研究概览
简要总结
This study evaluates visual outcomes and patient-reported satisfaction following bilateral cataract surgery using a non-diffractive extended depth-of-focus (EDOF) intraocular lens (AcrySof IQ Vivity). The purpose of the study is to assess distance, intermediate, and near visual acuity, refractive accuracy, contrast sensitivity, spectacle independence, and the presence of photic phenomena after implantation. Thirty patients undergoing bilateral phacoemulsification will be enrolled. Participants will be evaluated at 1 and 3 months postoperatively.
详细描述
This prospective, single-arm interventional study was designed to evaluate visual performance and patient-reported outcomes following bilateral implantation of a non-diffractive extended depth-of-focus (EDOF) intraocular lens in patients undergoing cataract surgery.
Modern cataract surgery aims not only to restore distance vision but also to provide functional intermediate and near vision while minimizing optical disturbances. Non-diffractive EDOF intraocular lenses utilize wavefront-shaping technology to extend the depth of focus without splitting light, with the objective of maintaining contrast sensitivity and reducing dysphotopsia compared to diffractive multifocal designs.
Eligible patients with age-related cataract underwent standard phacoemulsification cataract surgery with in-the-bag implantation of the study intraocular lens in both eyes. The target postoperative refraction was emmetropia. All procedures were performed under topical anesthesia using a standardized surgical technique. Postoperative treatment consisted of topical antibiotic-steroid therapy with a gradual taper.
Participants were evaluated at predefined postoperative visits to assess visual acuity at multiple distances, refractive status, defocus performance, contrast sensitivity, and patient-reported measures including spectacle independence and visual disturbances.
The study was conducted in accordance with institutional ethical standards and the principles of the Declaration of Helsinki. Ethical approval was obtained from the institutional review board of Al-Azhar University Faculty of Medicine (Approval No. Ophth._12/2023), and written informed consent was obtained from all participants prior to enrollment.
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
盲法说明
No masking was applied. Both the surgeon and patients were aware of the intervention. Outcome measures were assessed objectively using standardized visual acuity testing and validated patient questionnaires.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract requiring bilateral phacoemulsification
- •Corneal astigmatism ≤1.0 diopter
- •Desire for postoperative spectacle independence
- •Age ≥40 years
- •Ability and willingness to provide written informed consent
排除标准
- •Previous ocular surgery in either eye
- •Macular degeneration
- •Corneal pathology
- •Any ocular comorbidity that may affect visual outcomes
- •Systemic conditions likely to affect vision or surgical outcomes
- •Inability to comply with postoperative follow-up visits or study assessments
研究组 & 干预措施
Bilateral Non-Diffractive EDOF IOL Implantation
All participants underwent standard bilateral phacoemulsification cataract surgery with implantation of the AcrySof IQ Vivity non-diffractive extended depth-of-focus (EDOF) intraocular lens in both eyes. Target refraction was emmetropia. Postoperative care included a 4-week taper of combined topical antibiotic-steroid drops. Visual acuity, intermediate and near vision, spectacle independence, patient satisfaction, and photic phenomena were assessed at 1 and 3 months postoperatively.
干预措施: AcrySof IQ Vivity EDOF Intraocular Lens (Device)
结局指标
主要结局
Binocular Uncorrected Distance Visual Acuity (UDVA)
时间窗: 1 month and 3 months postoperatively
Binocular uncorrected distance visual acuity will be measured using standardized logMAR charts under photopic conditions following bilateral implantation of the study intraocular lens.
Monocular Uncorrected Distance Visual Acuity (UDVA)
时间窗: 1 month and 3 months postoperatively
Monocular uncorrected distance visual acuity will be assessed in each eye separately using standardized logMAR charts under photopic conditions.
Binocular Uncorrected Intermediate Visual Acuity (UIVA at 66 cm)
时间窗: 1 month and 3 months postoperatively
Binocular uncorrected intermediate visual acuity at 66 cm will be measured using standardized logMAR charts to evaluate intermediate functional vision.
Binocular Uncorrected Near Visual Acuity (UNVA at 40 cm)
时间窗: 1 month and 3 months postoperatively
Binocular uncorrected near visual acuity at 40 cm will be measured using standardized logMAR charts to assess near functional vision.
次要结局
未报告次要终点
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer
Benha University