Senile cataract not specified
Conditions
Interventions
The sample size to study is predicted to have 300 subjects allocated in one group.
Calculation of IOL power
The participants of the study will be submitted to optical and ultrasonic biometrics by the
Device
Procedure/surgery
Other
Sponsors
Hospital Evangélico de Belo Horizonte
Hospital Evangélico de Belo Horizonte
Eligibility
Age
21 Years to No maximum
Inclusion 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 cataract extraction by 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 follow-up examinations for a minimum of 1 year after cataract surgery. Patients requiring intraocular lens implantation powers ranging from 10 to 30 diopters. Patients with a visual potential of 20/40 or better in the eye indicated for intraocular lens implantation. Patients with a corneal cylinder corrected for less than 1 diopter.
Exclusion criteria
Exclusion criteria: Patients with any pathology of the anterior segment in which the intracapsular facectomy procedure with primary IOL implant is contraindicated (examples: keratoconus, dystrophy or corneal scars, anterior uveitis). Patients with corneal inflammation or edema, including but not limited to: keratitis, keratoconjunctivitis and ceratouveitis. Patients with uncontrolled glaucoma or glaucoma under treatment. Patients with history of retinal detachment. Patients with diabetic retinopathy (proliferative or non-proliferative). Patients with congenital, metabolic, traumatic or complicated cataract. Patients with marked microphthalmia or aniridia. Patients who had previous ocular surgery of the proposed eye. Patients who have already received other IOLs in the contralateral eye. Irregular corneal astigmatism. Amblyopia. Clinically significant changes in the retinal / macular pigment epithelium. Neovascularization of the iris, the camerular and retinal angle. Severe recurrent inflammation of the anterior or posterior segment of unknown etiology. Optical atrophy. Patients with immunodeficiency (infectious, neoplastic or drug). Patients on chronic systemic steroid use or immunosuppressive drugs. Patients simultaneously participating in another clinical trial. Patients with a strong dependence on intermediate vision, night vision, or specific occupational requirements (eg, commercial pilots and professional drivers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety of the different models of IOLs implanted, observing, describing and characterizing adverse events that are directly related to IOL, for example: presence of inflammation, IOL positioning in both postoperative of the late, displacement and decentralization of the IOL, presence and intensity of opacity formation in the posterior capsule, presence of edema after macular facectomy. ;Evaluation of visual acuity without correction for distance and near using the table of Snellen in the metric equivalent to 6 meters and high contrast, and Jaeger table positioned at 30 cm distance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the quality of life comparing before and after the IOL implantation using the NEI VFQ-25 questionnaire validated for the Portuguese language. | — |
Countries
Brazil
Contacts
Public ContactVinicius de Castro
Hospital Evangélico de Belo Horizonte
Outcome results
None listed