RBR-772s6y尚未招募4 期
Study of the effectiveness and efficiency of a new family of single-focal and multifocal introcular lenses under the Customized Cataract Solution project
João Marcelo de Almeida Gusmão Lyra0 个研究点开始时间: 2020年6月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 21Y 至 99Y（—）
入选标准
- •Patients who had a clinically documented diagnosis of age-related cataract (cortical, nuclear, sub-capsular or a combination) that was considered amenable to treatment by extraction of the cataract using the intracapsular facectomy method. Adult patients 21 years of age or older. Patients eligible for primary intraocular lens implantation. Patients willing and able to perform clinical and complementary exams for follow-up for a minimum of 1 year after cataract surgery. Patients requiring intraocular lens implantation powers ranging from 10 to 30 diopters. Patients with visual potential of 20/40 or better in the eye indicated for intraocular lens implantation. Patients with corneal cylinder to correct less than 1 diopter.
排除标准
- •Patients with the best corrected visual acuity less than or equal to 20/200 in the contralateral eye.
- •Patients with any pathology of the anterior segment in which the intracapsular facectomy procedure with primary IOL implantation is contraindicated (examples: keratoconus, corneal dystrophies or scars, anterior uveitis).
- •Patients with corneal inflammation or edema, included and not limited to: keratitis, keratoconjunctivitis and keratitis.
- •Patients with uncontrolled glaucoma or glaucoma under treatment.
- •Patients with a history of retinal detachment.
- •Patients with diabetic retinopathy (proliferative or non-proliferative).
- •Patients with congenital, metabolic, traumatic or complicated cataracts.
- •Patients with marked microphthalmia or aniridia.
- •Patients who have had previous proposed eye surgery.
- •Patients who have already received another IOL in the contralateral eye.
- •Irregular astigmatism of the cornea.
- •Clinically significant changes in the retinal pigment epithelium / macula.
- •Neovascularization of the iris, camerular and retinal angles.
- •Severe recurrent inflammation of the anterior or posterior segment of unknown etiology.
- •Optic atrophy.
- •Patients with immunodeficiency (infectious, neoplasic or medicated)
- •Patients on chronic use of systemic steroids or immunosuppressive drugs.
- •Patients participating in another clinical trial simultaneously.
- •Patients with strong dependence on intermediate vision, night vision or specific occupational requirements (examples: commercial pilots and professional drivers).
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