Retrospective Evaluation of the Tecnis Eyhance and OphthalmoPro Zoe Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Visual acuity
研究概览
简要总结
The goal of this observational study is to assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs). The main outcomes are:
To assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs) To assess depth of focus of the IOLs To assess tilt and decentration of the IOLs
The potential participants will be chosen from the list of patients in the Southend NHS database who have had routine cataract surgery using the Zoe or Eyhance lenses in the past 12 months and contacted by phone and letter. The member of the ophthalmological team carrying out the screening will use the research inclusion and exclusion criteria to identify 50 potential participants. Once identified, the potential participants will be asked if they would be willing to discuss inclusion into the study with a member of the clinical care team (Prof Myerscough or Dr Law). If they agree, they will be asked to attend one further clinical visit.
They will be given a patient information sheet and consent form at this visit. All potential participants will be informed that participation in this research study will be entirely voluntary.
At the clinical visit participants will have their vision assessed, have dilating drops instilled, and undergo two non-invasive scans of their eyes.
详细描述
Background and rationale:
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type and provide excellent distance vision following cataract surgery, however spectacles are required for reading and intermediate distance tasks.
The evolution of IOLs has been rapid over the last 50 years and there are now monofocal IOLs on the market (available to NHS hospitals) which aim to improve intermediate (computer distance) vision by increasing depth of focus.
There is currently little evidence to support which optical design provides the best visual outcome and existing literature for visual outcomes of intraocular lenses are largely derived from either ex-vivo bench studies, or tightly controlled groups in research settings with far reaching exclusion criteria. The idea of this retrospective study was to provide more data on how lenses perform in a busy NHS corneal service, not excluding (most) corneal comorbidity. The study aims to evaluate two of the monofocal IOLs that have been routinely used at Southend NHS hospital.
This research project is a retrospective study involving 50 subjects who have already received one of two standard treatment monofocal IOLs; the Ophthalmo Pro Zoe and the Tecnis Eyhance. Potential participants will be invited to attend an additional study visit at the hospital where their visual outcomes will be evaluated. There will be no comparison between the lenses therefore there is no need to match the participants or split the groups evenly.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (over 18) patients with cataract requiring cataract surgery with phacoemulsification and intraocular lens implantation.
- •Patients who have had either an OphthalmoPro Zoe or a Tecnis Eyhance monofocal lens implanted during routine cataract surgery within the past year
排除标准
- •Previous penetrating keratoplasty or anterior lamellar keratoplasty
- •Patients who are not willing to cooperate for the follow up period
- •Patients where it is not possible to take informed consent
结局指标
主要结局
Visual acuity
时间窗: From enrollment to the clinical assessment at 3 months
To assess distance and near visual acuity of patients who have undergone cataract surgery with two intraocular lenses (IOLs)
次要结局
- Depth of focus(From enrollment to the clinical assessment at 3 months)
- Tilt(From enrollment to the clinical assessment at 3 months)
- Decentration(From enrollment to the postoperative visit at 3 months)