Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract Refractive Lens Exchange

Keywords

cataractmultifocal IOL

Outcome Measures

Primary Outcomes (1)

Mean monocular best-corrected distance visual acuity (CDVA)
The objective is to evaluate Corrected Distance Visual Acuity (CDVA)
Three (3) Months

Secondary Outcomes (1)

Refractive Predictability / Manifest Refraction and Prediction Error
Twelve (12) Months

Other Outcomes (11)

Uncorrected Visual Acuities
Twelve (12) Months
Corrected Distance Visual Acuities
Twelve (12) Months
Corrected Intermediate and Near Visual Acuities
Twelve (12) Months
+8 more other outcomes

Study Arms (1)

Bilateral implantation of investigational device

OTHER

Bilateral implantation of investigational device

Device: AT ELANA

Interventions

AT ELANADevice

The device is CE-approved. The device is a posterior chamber multifocal intraocular lens (IOL) indicated for aphakia after surgical extraction of the cataractous natural lens. The device is also indicated for non-cataractous, presbyopic patients (PRELEX) who seek greater independence from glasses for intermediate and/or near distances. It is an aspheric (aberration-neutral) IOL made of hydrophobic acrylic material, coated with heparin with modified C-loop haptics.

Bilateral implantation of investigational device

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or older;
Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D

Sponsors & Collaborators

Carl Zeiss Meditec AG
Industrylead

Study Sites (3)

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

PVK Precise Vision GmbH

Rheine, 48429, Germany

Ofatlivist Alicante

Alicante, 03001, Spain

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Enrollment

69 participants (actual enrollment reported by the registry).

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

October 18, 2023

First Posted

November 1, 2023

Study Start

October 31, 2023

Actual (reported)

Visual Performance of Patients Implanted With a Multifocal IOL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (11)

Study Arms (1)

Bilateral implantation of investigational device

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (11)

Study Arms (1)

Bilateral implantation of investigational device

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations