Visual Outcomes and Patient Satisfaction After the Implantation of Isopure Extended-Depth-of-Focus Intraocular Lens (EDOF-IOL), With a Mini-Monovision Target
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- UIVA
研究概览
简要总结
Single-center, retrospective, open-label observational study aiming to evaluate visual outcomes and patient satisfaction after bilateral implantation of Isopure® EDOF-IOL with a mono-minovision target.
详细描述
This single-center retrospective study investigates visual outcomes and patient satisfaction in subjects bilaterally implanted with Enhanced-Depth of Focus (EDOF) Isopure® IOL during routine bilateral cataract surgery.
The study is carried out in an ophthalmic clinic in Switzerland. In this study, routine surgical techniques and postoperative follow-up will be applied as for all other (non-study) cataract patients in the clinic. Therefore, all study patients will be operated in immediate consecutive bilateral mode (routine in clinic). Patients participating in this study will be recruited and enrolled postoperatively. They undergo routine postoperative follow-up examinations, and data are collected at the third scheduled examination (4 to 6 weeks after surgery) and at a telephone call 4 to 6 months after surgery.
Isopure 1.2.3 is a CE certified intraocular lens readily available on the market in Switzerland.
The primary outcome consists in demonstrating a preserved distance visual acuity while improving binocular spectacle-free intermediate vision and, to a lesser extent, near vision. Binocular defocus curves are measured for each participant to simulate visual acuity at different distances. Patient satisfaction with treatment and subjective ratings of visual phenomena will be assessed using a modified PRISQ questionnaire and a modified NEI quality of vision questionnaire (RQL-42) at the third postoperative visit and three months after surgery.
At Vista Alpina Eye Clinic, mini-monovision is routinely used to further improve binocular intermediate and near vision while preserving the quality of distance vision in patients implanted bilaterally with EDOF Isopure® IOLs. Analysis of the retrospective data should help support this surgical strategy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male or female patients aged 50 years or older undergoing a routine cataract surgery and benefiting from bilateral IOL implantation with Isopure 1.2.3 IOL;
- •Patient's willingness to participate in the study;
- •Capacity to understand and sign an informed consent form and comply with examination procedures;
- •Cataractous eyes with no vision-impacting comorbidity (estimated visual potential post-surgery 0.2 logMAR or better);
- •Regular total corneal astigmatism ≤1.5 D (measured by topography method)
排除标准
- •Cooperation difficulties (distance from home, general health conditions, cognitive impairment);
- •Subjects with diagnosed extra- or intraocular vision-affecting comorbidities (macular degeneration, glaucoma or other retinal or optic nerve disorders, previous ocular surgeries, amblyopia);
- •Patients who previously benefitted from refractive surgery (PRK/LASIK) were included if no refractive surgery-related complications were noted (i.e: ectasia, corneal haze, dry eye);
- •History or presence of macular edema;
- •Perioperative complications;
- •Congenital, uveitic, traumatic or surgically-complicated cataract
- •Regular total corneal astigmatism >1.5 dioptres (measured by topography method)
- •Irregular cornea, including keratotomy
结局指标
主要结局
UIVA
时间窗: 4-6 weeks postoperatively
Binocular Uncorrected Intermediate Visual Acuity (80 cm)
UNVA
时间窗: 4-6 weeks postoperatively
Binocular Uncorrected Near Visual Acuity (40 cm)
UDVA(m)
时间窗: 4-6 weeks postoperatively
Monocular Uncorrected Distance Visual Acuity
CDVA(m)
时间窗: 4-6 weeks postoperatively
Monocular Corrected Distance Visual Acuity
UDVA(b)
时间窗: 4-6 weeks postoperatively
Binocular Uncorrected Distance Visual Acuity
Defocus curve
时间窗: 4-6 weeks postoperatively
Binocular distance-corrected defocus curve analysis simulating visual acuities at different distances.
次要结局
- Subjective rating of visual phenomena(4-6 weeks postoperatively and 4-6 months postoperatively)
- Patient satisfaction with the visual outcome(4-6 weeks postoperatively and 4-6 months postoperatively)
研究者
Kristof Vandekerckhove, MD, MBA
Medical Director and Founder, Vista Alpina Eye Clinic
Vista Alpina Eye Clinic