Fellow Eye Study Evaluating Correlation Between Sulcus Anatomy and Ocular Parameters Using Ultrasound Biomicroscopy (UBM) After Horizontal or Vertical Placement of the Intraocular Lens (IOLs) in the Capsular Bag
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Sulcus diameter versus anterior chamber dimension
研究概览
简要总结
Usually following cataract surgery patients would expect to have normal distance vision and not require the use of distance glasses. However, in clinical practice desired vision post cataract surgery is not achieved sometimes. In such cases a piggyback lens is used to enhance the visual outcome. This lens is placed in the ciliary sulcus (space between the iris and the lens). Often this piggyback lens is not the best fit for the ciliary sulcus space and it moves. This study will be using ultrasound biomicroscopy to measure the ciliary sulcus dimensions pre and postoperatively to estimate the normal anatomy and it's variations. Patients in this study will be randomised as to which way the intraocular lens is placed in the eye (horizontally or vertically) at the time of their cataract surgery. Patients requiring cataract surgery in both eyes will be identified from the Eye Hospital at the Royal Sussex County Hospital. Patients will be in the study for up to 6 months from being identified as suitable through to the operation in the 2nd eye and a final study visit.
详细描述
Study Design This is a prospective, fellow eye randomised study.
Recruitment
A sample size of 92 eyes (46 patients) was calculated. Patients will be recruited at the Sussex Eye Hospital preoperative cataract assessment clinics where they will be screened and given a patient information sheet by a member of the research team if they can be recruited. They will be allowed to take this home to discuss with their family/friends and/or GP. They will be asked if the research team could contact them in a weeks time to discuss the study and the plan for the day of their surgery (which is their next NHS visit). Patients can then agree or decline to participate in the study . If they decline, their normal NHS pathway will continue. If they accept, written informed consent will be taken on the day of surgery as well as any extra imaging required. The key points of the trial will be reiterated and the patient will be invited to ask any questions. All members of the research team are NIHR GCP trained. All research patients will undergo surgery by the same surgeon and attend for post-operative follow-up at the Sussex Eye Hospital. In addition at this visit a research appointment will be made to undertake the research scans and examinations (see details below) by an experienced member of our research team. The research team including the surgeon cannot be blinded as the obvious direction of placement of the intraocular lens will be visible during surgery and during examination.
Pre-operative appointment
Consent If the patient would like to participate they will be asked to read and sign a consent form. If the patient gives consent for their GP to be notified of their participation in the study a letter will be sent to the GP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cataracts undergoing cataract extraction in both eye.
- •Diopters of corneal astigmatism Scheimpflug imaging (Pentacam HR, Oculus, Germany)
排除标准
- •Less than 18 years
- •Significant ophthalmic co-morbidity that may affect the anatomy of the eye
- •Not competent to give fully informed consent
- •Unable to have surgery and attend follow up appointment at Sussex Eye Hospital, Brighton
结局指标
主要结局
Sulcus diameter versus anterior chamber dimension
时间窗: 1 month
Correlations between sulcus diameter and anterior chamber dimensions in the 4 axes pre and post operatively and also for the differences post and pre operatively.
次要结局
- Rotation of the IOL in degrees from it's primary placement at 4-6 weeks at postoperative follow up.(1 month)
- Changes in anterior chamber depth following cataract extraction(1 month)
- Changes in sulcus diameter in 4 axes in eyes with vertical and horizontal placement of IOLs(1 month)
- Changes in anterior chamber diameter following cataract extraction(1 month)
- To explore any relationship between demographics in relation to sulcus anatomy(1 month)