In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

AST Products

Status: Completed

Conditions: Intraocular Lens Complication; Cataract

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04971863

ASQM012021

Details and patient eligibility

About

This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.

Full description

This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.

Enrollment: 200 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL

Exclusion criteria

• Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
• Previous ocular surgery
• Rubella
• Surgery motivated by traumatic cataract
• Ocular trauma or refractive surgery
• Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study
• Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.

Trial design

200 participants in 2 patient groups

Clareon Monofocal IOL

Description:

Patients bilaterally implanted with the Clareon monofocal IOL

Asqelio Monofocal IOL

Description:

Patients bilaterally implanted with the Asqelio monofocal IOL