Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens

NCT04907500 | Completed

• 1 other identifier: LISA 809 BER-401-20
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

• Monocular corrected distance visual acuity (CDVA)

  Monocular corrected distance visual acuity measured in logMAR

  6 months after the implantation

Study Arms (1)

Multifocal IOL

EXPERIMENTAL

Implantation of a multifocal intraocular lens

Device: Intraocular lens

Interventions

Intraocular lens DEVICE

Cataract surgery

Multifocal IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any gender, aged 18 years or older
• Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye
• Patient is willing and capable of providing informed consent
• Patient is willing and capable of complying with visits and procedures as defined by this protocol

You may not qualify if:

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
• Endothelial cell count of less than 2000/mm2
• Ocular disorder that could potentially cause a clinically significant future visual acuity loss
• Preoperative corneal astigmatism ative corneal to be \< 1 D.
• Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
• Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
• Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
• Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
• Any acute infection (acute ocular disease, external/internal infection, systemic infection)
• Any previous intraocular and corneal surgery
• Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
• Current systemic or ocular pharmacotherapy that effects patients'vision
• Current pathology or condition that could be a risk for the patient according to the investigator opinion
• Women during pregnancy and/or lactation
• Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

DUO STIL SRL , Clinica Oftalmologica Medoptic

Suceava, Romania

Location

MeSH Terms

Interventions

Lenses, Intraocular

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: June 22, 2021
• Primary Completion: August 6, 2022
• Study Completion: December 16, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

RO (1)