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Clinical Trials/RBR-8g9897
RBR-8g9897
Not yet recruiting
未知

Evaluation of the efficacy and safety of new models of intraocular lenses for cataract surgery.

Associação Evangélica Beneficente de Minas Gerais0 sitesAugust 3, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Senile cataract not specified
Sponsor
Associação Evangélica Beneficente de Minas Gerais
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 3, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Intervention

Investigators

Sponsor
Associação Evangélica Beneficente de Minas Gerais

Eligibility Criteria

Inclusion Criteria

  • 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.

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 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).

Outcomes

Primary Outcomes

Not specified

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