Evaluation of a Trifocal Lens

Sponsor

Carl Zeiss Meditec AG (Industry)

Overall Status

Completed

CT.gov ID

NCT04545671

Collaborator

(none)

389

Enrollment

Location

16.4

Actual Duration (Months)

23.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract Senile	Other: trifocal lens

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

389 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Mar 16, 2022

Actual Study Completion Date :

Mar 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients already implanted with study lens No intervention as patients are already implanted.	Other: trifocal lens not applicable as patients are already implanted with the trifocal lens

Arm

Intervention/Treatment

Patients already implanted with study lens

No intervention as patients are already implanted.

Other: trifocal lens

not applicable as patients are already implanted with the trifocal lens

Outcome Measures

Primary Outcome Measures

Visual acuity [12 to 24 months after the implantation]
Visua acuity at far, intermediate and near distances

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Augencentrum Michelfield	Michelfeld	Baden-Württemberg	Germany	74545

Sponsors and Collaborators

Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carl Zeiss Meditec AG

ClinicalTrials.gov Identifier:

NCT04545671

Other Study ID Numbers:

LISA tri 839 BER-401-19

First Posted:

Sep 11, 2020

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jul 20, 2022