Efficacy and safety evaluation of new model of intraocular lenses for cataract surgery.

Not Applicable

• Conditions: Senile cataract not specified; Not specified cataract; H25.9; H26.9

• Registration Number: RBR-56xh4c
• Lead Sponsor: Hospital Evangélico de Belo Horizonte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Intervention
• Study Design: Not specified