Clinical Outcome at 5 Years After Implantation of Medicontur Multifocal Intraocular Lens Liberty 677MY: Visual Outcomes, Patients' Satisfaction, YAG Capsulotomy Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Corrected Decimal VA (6 m)
研究概览
简要总结
The study will assess visual outcomes, light disturbances and patients' satisfaction after implantation with the Liberty677MY multifocal IOL, as well as protection of PCO development within 5 year follow-up.
详细描述
The Liberty677MY multifocal IOL is designed for restoring near, intermediate and distance vision. The technology of Liberty 677MY is based on the elevated phase shift technology (patent pending). Previous evaluations showed the strength of studied IOL both in laboratory and clinical conditions.
Patients will be examined 5 years after implantation. The examination will include the measurement of the best corrected distance, intermediate and near visual acuity (assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts), intraocular pressure (contact Goldman tonometry), biomicroscopic and fundocsopic examination, contrast sensitivity (CSV-1000), defocus curve, reading capability, pupilometry in different light conditions and PCO evaluation, Nd:YAG capsulotomy rate, photo-documentation of anterior segment. YAG capsulotomy will be indicated in case of posterior capsule opacification (PCO). The criteria for YAG capsulotomy will be visual acuity decreased 2 or more lines when using (ETDRS) charts. Details of all related and unrelated complications will be documented, including severity, time of onset, specific treatment and clinical outcome. The investigators will also record whether the capsulorhexis is on or partially off the optic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pseudophakic patients implanted with Liberty 677MY in 2014-2015 during the study under the ethical approval: 059823/2014/OTIG
排除标准
- •diabetic retinopathy
- •iris neovascularisation
- •serious intraoperative complications
- •congenital eye abnormality
- •pseudoexfoliation syndrome
- •amblyopia
- •long-term anti-inflammatory treatment
- •AMD (advanced AMD)
- •retinal detachment
- •prior ocular surgery in personal medical history (except cataract surgery aiming the implantation of the multifocal IOL)
- •previous laser treatment
- •corneal diseases
- •severe retinal diseases (dystrophy, degeneration)
- •severe myopia (if required IOL power is lower than 10 D)
- •inadequate visualization of the fundus on preoperative examination
- •patients deemed by the clinical investigator because of any systemic disease.
- •pregnancy
- •eye trauma in medical history
- •current use of systemic steroids or topical ocular medication
- •preoperative smaller pupil size of 6 mm under topical mydriasis
- •kappa angle >5°
结局指标
主要结局
Corrected Decimal VA (6 m)
时间窗: 5 years after implantation
Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 6 meters (m) using ETDRS charts, assessed in LogMAR.
Defocus Curve Profiles
时间窗: 5 years after implantation
Visual acuity measurement (assessed in logarithm of the minimum angle of resolution (LogMAR)) taken with different levels of optical defocus was tested monocularly (each eye separately) and binocularly (both eyes together).
Uncorrected Decimal VA (6 m)
时间窗: 5 years after implantation
Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 6 meters (m) using Early Treatment Diabetic Retinopathy ( ETDRS) charts and assessed in logarithm of the minimum angle of resolution (LogMAR).
Uncorrected Decimal VA (60 cm)
时间窗: 5 years after implantation
Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 60 centimeters (cm) using ETDRS charts, assessed in LogMAR.
Uncorrected Decimal VA (40 cm)
时间窗: 5 years after implantation
Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 40 centimeters (cm) using ETDRS charts, assessed in LogMAR.
Corrected Decimal VA (60 cm)
时间窗: 5 years after implantation
Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 60 centimeters (cm) using ETDRS charts , assessed in LogMAR.
Corrected Decimal VA (40 cm)
时间窗: 5 years after implantation
Visual acuity (VA) was tested monocularly (each eye separately) and binocularly (both eyes together) 5 years after implantation, unaided at a distance of 40 centimeters (cm) using ETDRS charts, assessed in LogMAR.
Contrast Sensitivity CSV-1000
时间窗: 5 years after implantation
Binocular Assessment of contrast sensitivity at threshold using the Contrast sensitivity vision (CSV) CSV-1000 in photopic and mesopic conditions with or without glare.
次要结局
- Posterior capsule opacification (PCO) rate(5 years after implantation)