Study of efficiency and effectiveness of a new family of introcular lenses

Phase 4

• Conditions: H26.9; nspecified senile cataract; unspecified cataract; H25.9

• Registration Number: RBR-772s6y
• Lead Sponsor: João Marcelo de Almeida Gusmão Lyra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• 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 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.
Irregular astigmatism of the cornea.
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.
Optic atrophy.
Patients with immunodeficiency (infectious, neoplasic 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, positioning of the IOL both in the immediate and late postoperative periods, displacement and decentralization IOL, presence and intensity of opacity formation in the posterior capsule, presence of macular edema after facectomy<br><br><br>;Evaluation of visual acuity without correction for distance and near using the Snellen table in the metric equivalent to 6 meters and high contrast, and the Jaeger table positioned 30 cm away

Secondary Outcome Measures

Name	Time	Method
Assessment of quality of life by comparing before and after IOL implantation using the NEI VFQ-25 questionnaire validated for the Portuguese language