Comparison of 2.2 mm vs 2.8 mm clear corneal wound characteristics following wound assisted IOL injection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Comparison of incidence of wound site Descemet membrane detachment in the three groups
研究概览
简要总结
This study aims to evaluate wound extension, IOL safety, Descemet membrane detachment and surgically induced astigmatism in phacoemulsification surgery using the wound assisted technique of IOL implantation and to study their relationship with incision size.
This will be a prospective, observational study conducted at Aravind Eye Hospital, Chennai. All surgeries will be performed by 4 experienced surgeons, using the Centurion Phacoemulsification system under topical or sub-Tenon’s anaesthesia. Surgery will be performed via standard clear corneal incisions of either 2.2mm or 2.8mm size depending on the intraocular lens that the patient has chosen. Once the cataract has been removed from the eye, the incision size will be measured by a device called incision gauge. Following this, the IOL will be injected through this incision inside the eye. The surgeon will once again measure the incision size after this step. The surgery would be concluded as usual. In the event of detecting any nicks, scratches or breaks of the intraocular lens (IOL) during its insertion, their presence will be duly observed and documented by the surgeon. ASOCT will be done for all patients to analyse wound size, wound gape and non-apposition of the incision and detect the presence of Descemet membrane detachment on post-operative day 1 and post-operative day 21. Biometry will be done for all participants pre-operatively, on post-operative day 21 and on post-operative day 90 to check for keratometry and surgically induced astigmatism.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with age related cataract Age 45 years and above Patients undergoing phacoemulsification surgery Phacoemulsification surgery done through a temporal incision Patients with intraocular lens power ranging from plus 18D to plus 25D Willing to participate in the study Willing for follow up visits.
排除标准
- •Pterygium Grade II and Grade III Previous ocular surgery Pre existing irregular astigmatism Corneal opacity Patients with Fuchs endothelial corneal dystrophy or significant guttata seen preoperatively Patients with arcus senilis Intraoperative obvious wound extension, tear or Descemet membrane detachment noted before IOL implantation Frank clinically significant DMD happening at the step of wound hydration, when it was not noticed prior to that point Intraoperative posterior capsular rent and zonular dehiscence Intraoperative use of iris hooks.
结局指标
主要结局
Comparison of incidence of wound site Descemet membrane detachment in the three groups
时间窗: Intra operatively | Post operative day 1 | Post operative day 21
次要结局
- Comparison of IOL safety(Intra operatively)
- Comparison of wound size extension(Intra operatively)
- Comparison of keratometry and surgically induced astigmatism(Post operative day 21)
研究者
Dr. Rajeshwari Kapoor
Aravind Eye Hospital
