Long-term Efficacy, Visual Performance and Patient Reported Outcomes With a Trifocal Intraocular Lens: Six-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Monocular visual acuity
研究概览
简要总结
The main aims of this study were to evaluate the patient reported outcomes (PROs), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the AT LISA tri 839MP. A secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis.
详细描述
Retrospective cross-sectional study with two stages:
• Phone call interview:
First stage included patient reported outcomes of visual function, spectacle independence and satisfaction through questionnaires conducted by a phone call in all the patients implanted in our center with AT LISA 839MP from March 2014 to June 2015 (n=92) which accomplished inclusion / exclusion criteria and were able to be contacted by phone (n=62).
The incidence of Nd-YAG capsulotomy was retrospectively evaluated through the revision of the medical history, in patients for which capsulotomy was conducted in our center, or a question, for those treated in another center.
• Study visit:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Phone call interview:
- •Patients of either sex, 45 years of age or older at the time of surgery and less than 80 years of age at the time of the phone call.
- •Patients implanted bilaterally with the AT LISA 839MP MIOL in the capsular bag.
- •No surgical complications reported in the clinical history that could affect postoperative visual acuity: damage to the capsular bag, intraocular hemorrhage, etc.
- •Operated between 66 months from the first implanted eye and up to 78 months from the surgery of the second eye
- •Patient able to hear, understand and give express consent orally.
- •Study visit:
- •To have participated in the first stage of the study corresponding to the phone call interview.
- •Irregular astigmatism in either eye measured with corneal tomography (total high-order corneal aberrations at 4 mm < 0.5 μm).
- •Patient able to read, understand and provide a written informed consent form.
- •Sufficient availability, willingness, skills, and cognitive awareness to comply with follow-up/study procedures and study visits.
排除标准
- •Phone call interview:
- •Any eye disease documented in the patient's clinical history that may potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
- •Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
- •Study Visit:
- •PCO ≥ 2 according to surgeon criteria that produces a loss of CDVA ≥ 0.2 logMAR
- •Any eye disorder that can potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
- •Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
- •Use of systemic or ocular medications that may affect vision in the last 6 months.
- •Subjects who participate in any clinical trial or research with drugs or medical devices within 30 days prior to entry into this research and/or during the period of participation in this research.
结局指标
主要结局
Monocular visual acuity
时间窗: 6 years
Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.
次要结局
- Satisfaction, Photic Phenomena and Operated again(6 years)
- Light distortion analysis in percentage(6 years)
- Visual Function Questionnaire (VF-14)(6 years)
- Contrast sensitivity defocus curve in logCS(6 years)
- Patient-Reported Spectacle Independence Questionnaire (PRSIQ)(6 years)