Evaluation of new models of intraocular lenses for cataract surgery.
- Conditions
- Senile cataract not specifiedNot specified cataractH25.9H26.9
- Registration Number
- RBR-8g9897
- Lead Sponsor
- Associação Evangélica Beneficente de Minas Gerais
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients who had a clinically documented diagnosis of age-related cataract (cortical, nuclear, sub-capsular, or a combination) who was considered amenable to treatment by
cataract extraction 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 tests for follow-up for a minimum period of 1 year after cataract surgery. Patients who require 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 cylinders to correct less than 1 diopter.
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 procedure of intracapsular facectomy 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 keratouveitis. 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 corneal astigmatism. Amblyopia. 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. Optical atrophy. Patients with immunodeficiency (infectious, neoplastic 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).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of the different models of the implanted IOL, observing, describing and characterizing adverse events that are directly related to the implantation of the IOL, for example: presence of inflammation, IOL positioning both in the immediate and late postoperative periods, displacement and decentralization of the IOL. IOL, presence and intensity of opacity formation in the posterior capsule, presence of macular edema after facectomy;<br><br>;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 Outcome Measures
Name Time Method Quality of life assessment comparing before and after IOL implantation using the NEI VFQ-25 questionnaire validated for the Portuguese language.