Study of the Incidence of Retinal Detachment After Lens Surgery in the Nearsighted
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 主要终点
- Posterior detachment of vitreous yes/no
研究概览
简要总结
This study aims to study the incidence of retinal detachment in the nearsighted myopic after phakoemulsification lens surgery and use of posterior chamber foldable soft implants with a follow-up of 5 years and preliminary results at 3 years.
详细描述
Major advances have been made in the field of lens surgery over the last 20 years which has significantly reduced the per and postoperative complications of this surgery. Retinal detachment remains the most feared complication of this surgery in the nearsighted.
There is currently an increasing popularity in the international ophthalmic community for the correction of ametropia, particularly nearsightedness, by ablation of the non-cataracted lens, referred to as refractive lensectomy. However, no recent study reports the complications of this procedure with the use of modern surgical techniques.
This study aims to study the incidence of retinal detachment in the nearsighted myopic after phakoemulsification lens surgery and use of posterior chamber foldable soft implants with a follow-up of 5 years and preliminary results at 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form.
- •Male or female aged 20 to 60 included.
- •Myopia: axile, united or bilateral.
- •Degree of myopia: Axial length of the eye to be operated ≥ 26 mm, measured by ultrasound A or B.
- •Preoperative visual acuity of the eye to be operated ≥ 0.
- •Crystalline eye to operate natural: clear or opacified (allowed: cataract complicating a myopic implant and cataract after corneal refractive surgery.
排除标准
- •History of retinal detachment on the eye to be operated or the eye to help.
- •History of glaucoma of the eye to operate.
- •intraocular pressure of the eye to operate ≥ 21 mmHg.
- •History of diabetic retinopathy.
- •History of anterior or posterior intraocular inflammation in the year preceding surgery.
- •History of vitreoretinal syndrome (Stickler's disease ...).
- •Unstable systemic pathology in the month preceding the preoperative check-up (Visit 1) (example: uncontrolled hypertension, diabetes with abnormal glycemia, thyroid disorders, uncontrolled autoimmune diseases, etc.) or deemed by the investigator to be incompatible with the study (example: hepatic or renal insufficiency, all severe chronic organic diseases: metabolic, endocrine, neoplastic, hematological, etc., severe psychiatric diseases).
- •Pregnancy, breastfeeding.
- •History of filter surgery of the eye to be operated.
- •History of vitreoretinal surgery of the eye to be operated (authorized after Day 0).
- •Patient unable to understand the instructions of the study or not likely to comply with the course of the study and treatment.
- •Participation in another clinical trial in the month preceding the start of this study, at the same time as this study.
- •Patient not covered by the French social security system.
- •Major patient under guardianship.
结局指标
主要结局
Posterior detachment of vitreous yes/no
时间窗: 3 months after surgery
With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
lesions of the retinal periphery yes/no
时间窗: 3 months after surgery
With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
Argon laser treatment scars yes/no
时间窗: 3 months after surgery
With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
tabby appearance without atrophy yes/no
时间窗: 3 months after surgery
With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
Presence of eye anomaly yes/no (myopic conus, Bruch's membrane breaks, deep chorioretinal atrophic cupboard with punch, deep choroidal atrophic cupboard showing sclera to bare)
时间窗: 3 months after surgery
With dilated fundus exam: the pupil will be dilated by instillation of a mydriatic eye drop. The bottom of the eye and the peripheral retina will be examined with a slit lamp with a Superfield lens or a glass with 3 mirrors.
次要结局
未报告次要终点