" Visual Outcomes Following Implantation Of A Wave Front Shaping IOL In Patients With Early Age-related Macular Degeneration: A Prospective, interventional Case Series Studyâ€
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Unaided and corrected distance visual acuity (LogMAR) at
研究概览
简要总结
Presbyopia correction in conjunction with cataractsurgery has been the holy grail for cataract surgeons. Today, severalmultifocal (bifocal / trifocal) IOLs are available that give excellent unaidedvisual acuity for distance, intermediate and near vision activities. However,inherent compromises of photic phenomena and reduction in contrast sensitivityoften mar the successful visual outcomes of diffractive multifocal IOLs. Thishas been a concern, particularly in eyes with pre-existing early, stablemacular degeneration. More surgeons today prefer monofocal IOL implantation ineyes with mild retinal compromise, including early dry macular degeneration. However,recently, the non-diffractive extended range of vision IOL (Vivity) has beenlaunched. It provides greater spectacle independence compared to monofocal IOLsand available reports show minimal to no photic phenomena as well as contrastsensitivity reduction. However, it is not yet clear whether the Vivity IOL willoffer a comparable quality of distance vision and a greater range of visionwithout significant compromise in the quality of vision in eyes with early drymacular degeneration. The aim of this study is to evaluate unaided and bestcorrected visual acuity at different distances and varying contrast levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with uncomplicated, age related cataracts and nuclear sclerosis ranging from grade I to IV on the LOCS III grading system and pre-existing stable, early dry age-related macular degeneration. Early dry AMD will be defined based on the AREDS 2 study criteria (i.e. Multiple small drusen <63 microns or few intermediate drusen >
- •<125 microns, or pigmentary changes at macula). Only one eye of each patient will be included.
排除标准
- •Choroidal neovascularization, severe dry AMD, large drusen, foveal thickness >300 microns on optical coherence tomography (OCT), macular hole on OCT, prior history of intravitreal injection / implant, other ocular comorbidities including but not limited to glaucoma, uveitis, pseudoexfoliation syndrome, zonular weakness, macular pathology, diabetic retinopathy, ocular coloboma etc.
- •nonreactive or irregular pupil, prior ocular surgery or trauma.
结局指标
主要结局
Unaided and corrected distance visual acuity (LogMAR) at
时间窗: 3 months
4 metres on the ETDRS chart
时间窗: 3 months
次要结局
- Unaided and corrected distance visual acuity (LogMAR) at(4 metres on the ETDRS chart)
