In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

NCT04971863 | Completed

• 1 other identifier: ASQM012021
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cataract; Intraocular Lens Complication

Keywords

posterior capsule opacitication; incidence

Outcome Measures

Primary Outcomes (2)

• Incidence of Posterior capsular opacity

  Incidence of PCO

  24 months after IOL implantation

• Intensity of Posterior capsular opacity

  Intensity of PCO determined using LOCSIII Classification System

  24 months after IOL implantation

Secondary Outcomes (5)

• Visual acuity

  1 month, 6 months, 12 months and 24 months after IOL implantation

• Refraction

  1 month, 6 months, 12 months and 24 months after IOL implantation

• Optical quality

  24 months after IOL implantation

• Incidence of Glistening

  24 months after IOL implantation

• Intensity of Glistening

  24 months after IOL implantation

Study Arms (2)

Clareon Monofocal IOL

Patients bilaterally implanted with the Clareon monofocal IOL

Asqelio Monofocal IOL

Patients bilaterally implanted with the Asqelio monofocal IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La Fé of Valencia, Spain

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AST Products, Inc.: lead
• Hospital Universitario La Fe: collaborator

Study Sites (1)

Hospital Universitario y Politécnico la Fe

Valencia, Spain

Location

Related Publications (1)

• Hervas-Ontiveros A, Espana-Gregori E, Fresno-Canada C, Butron-Ruiz R, Cervino A. Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study. J Ophthalmol. 2024 Dec 31;2024:3520219. doi: 10.1155/joph/3520219. eCollection 2024.

  PMID: 39781444 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: March 30, 2022
• Primary Completion: October 31, 2023
• Study Completion: January 5, 2024
• Last Updated: January 31, 2024

Record last verified: 2023-02

Locations

ES (1)