In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

Cataract Clinical Trial

Official title:

In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971863
• Other study ID #: ASQM012021
• Status: Completed
• Start date: March 30, 2022
• Est. completion date: January 5, 2024

Study information

• Verified date: February 2023
• Source: AST Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 5, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Intraocular Lens Complication

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politécnico la Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
AST Products, Inc.	Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Posterior capsular opacity	Incidence of PCO	24 months after IOL implantation
Primary	Intensity of Posterior capsular opacity	Intensity of PCO determined using LOCSIII Classification System	24 months after IOL implantation
Secondary	Visual acuity	Best corrected distance visual acuity in LogMAR units using the ETDRS chart	1 month, 6 months, 12 months and 24 months after IOL implantation
Secondary	Refraction	Residual refractive error in diopters determined objectively	1 month, 6 months, 12 months and 24 months after IOL implantation
Secondary	Optical quality	Higher-order wavefront aberrations determined using a clinical wavefront analyzer	24 months after IOL implantation
Secondary	Incidence of Glistening	Incidence of IOL glistening	24 months after IOL implantation
Secondary	Intensity of Glistening	Intensity of IOL glistening	24 months after IOL implantation