Influence of Posterior Vitreous Detachment on Retinal Detachment After Lens Surgery in Myopic Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 609
- 试验地点
- 1
- 主要终点
- PVD status
研究概览
简要总结
Phacoemulsification with implantation of posterior chamber lenses represents the gold standard of care for patients needing lens surgery, but there is an increased risk of developing pseudophakic retinal detachment after surgery. Especially myopic patients have an even higher risk of pseudophakic retinal detachment compared to the general population.
The aim of this multicenter study is to document the presence and/or post-operative development of posterior vitreous detachment (PVD) and to assess its influence on the incidence of retinal detachment (RD) in myopes in a time period of three and five years after lens surgery.
618 eyes of patients scheduled for regular lens surgery will be included, defined by an axial length of 25.0 mm or more. To examine the vitreous status, all patients will receive a comprehensive eye examination pre-operatively, including funduscopy with assessment of a Weiss ring and optical coherence tomography (OCT). Patients will be divided into two groups, group A with pre-operative complete PVD and group B with no/partial PVD. Group A will be invited for one follow-up visit (two months post-operatively) followed up by telephone interviews at one, two, three and five years after surgery to determine occurrence of pseudophakic retinal detachment. Group B will be invited for follow-up examinations at two months, six months and one year after surgery to document occurrence of PVD (if a PVD is present at one of the follow-ups, no more visits are necessary). Two, three and five years after surgery, all patients from group B will be interviewed by telephone, as in group A, to document the occurrence of pseudophakic retinal detachment.
In the recent literature the association between the occurrence of PVD pre-/post-operative and RD after lens surgery is well documented but not described for myopic patients. The results of this multicenter study should help to tackle the problem of RD prediction in myopic patients depending on their pre-operative vitreous status, especially in the setting of refractive lens exchange.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 21 years of age
- •Patients scheduled for lens surgery with an axial eye length of 25.0 mm or more
- •Availability, willingness, sufficient cognitive awareness to comply with examination procedures
- •Ability to sign informed consent
排除标准
- •Patients with combined surgery (e.g. combined phacoemulsification and vitrectomy or trabeculectomy or DSAEK)
- •Patients with previous intraocular surgery (except any kind of laser surgery e.g. retinopexy, refractive laser surgery)
- •Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown aetiology, or any disease producing an inflammatory reaction in the eye
- •Any ophthalmological pathology with the potential to compromise the measurements (e.g. mature/very dense cataract, fixation difficulties)
- •Penetrating ocular trauma
- •Previous history of retinal detachment
- •Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
- •Patients participating in another study
结局指标
主要结局
PVD status
时间窗: 1 year
Number of patients with preoperative and/or post-operatively developed posterior vitreous detachment (PVD)
Incidence of RD
时间窗: 5 years
Influence of PVD on the incidence of retinal detachment (RD) in myopes after lens surgery.
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principle Investigator, Sponsor
Vienna Institute for Research in Ocular Surgery