Evaluation of a Trifocal Lens

NCT04545671 | Completed

• 1 other identifier: LISA tri 839 BER-401-19
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Visua acuity at far, intermediate and near distances

  12 to 24 months after the implantation

Study Arms (1)

Patients already implanted with study lens

No intervention as patients are already implanted.

Other: trifocal lens

Interventions

trifocal lens OTHER

not applicable as patients are already implanted with the trifocal lens

Patients already implanted with study lens

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with the study lens IOLs

You may qualify if:

• Patients of any gender, aged 45 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 an the study lens 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

Augencentrum Michelfield

Michelfeld, Baden-Wurttemberg, 74545, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 11, 2020
• Study Start: November 1, 2020
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)