RBR-772s6y
Not yet recruiting
Phase 4
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 sitesJune 4, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- nspecified senile cataract
- Sponsor
- João Marcelo de Almeida Gusmão Lyra
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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