Safety and Effectiveness of an Hydrophilic Acrylic Intraocular Lens

NCT ID: NCT04789538

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 328 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-04-01

Brief Summary

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

Detailed Description

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.

Conditions

Cataract Senile

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Monofocal IOL

monofocal lens

Intervention Type: OTHER

not applicable as patients are already implanted with the monofocal intraocular lens

Interventions

monofocal lens

not applicable as patients are already implanted with the monofocal intraocular lens

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients of any gender, aged 18 years or older at the time of the surgery
• Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
• Currently implanted with the study device into the capsular bag in at least one eye
• One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
• 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

Exclusion Criteria

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
• Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
• Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
• Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
• Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
• Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
• Any preoperative documented 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 preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
• Any previous preoperative intraocular and corneal surgery
• Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
• Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
• Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
• Women during pregnancy and/or lactation at time of enrollment into the study
• Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
• Patients whose freedom is impaired by administrative or legal order
• Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Desgenettes

Lyon, , France

Countries

France

Other Identifiers

ASPHINA 509 BER-401-20

Identifier Type: -

Identifier Source: org_study_id