Visual Performance of Patients Implanted With a Multifocal IOL

Cataract Clinical Trial

— VISUAL  

Official title:

Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111222
• Other study ID #: GPAS-SUR-021-01
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Carl Zeiss Meditec AG
• Contact: Grant Sharpe
• Phone: +441223401450
• Email: grant.sharpe[@]zeiss.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• No visual acuity limiting pathologies other than cataract;

• Corneal Astigmatism of <1.0 D;

• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;

• Written informed consent for participation in the study and data protection.

Exclusion Criteria:

• Corneal Astigmatism of =1.0 D;

• Difficulty for cooperation (distance from their home, general health conditions);

• History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);

• Visual field loss which has an impact on visual acuity;

• Use of systemic or ocular medication that might affect vision;

• Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;

• Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);

• Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);

• Cataract grades of 4, 5 or 6 on the LOCSIII scale ;

• Surgeries with incision size of =2.75mm ;

• Immediate Sequential Bilateral Cataract Surgery ;

• Concurrent participation in another device investigation;

• Usage of contact lenses during participation.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• HECATE
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.

Locations

Country	Name	City	State
Spain	Dr. Pedro Tañá Rivero	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Uncorrected Visual Acuities	Binocular uncorrected distance, intermediate and near visual acuity (UDVA, UIVA, UNVA)	Twelve (12) Months
Other	Corrected Distance Visual Acuities	Best-corrected monocular and binocular distance visual acuity (CDVA)	Twelve (12) Months
Other	Corrected Intermediate and Near Visual Acuities	Binocular Distance-corrected intermediate and near visual acuity	Twelve (12) Months
Other	Refractive predictability		Twelve (12) Months
Other	Patient Reported Outcome Measures (PROMs)		Three (3) Months
Other	Postoperative use of spectacles		Twelve (12) Months
Other	Defocus Curves	Monocular and Binocular	Twelve (12) Months
Other	Binocular Contrast Sensitivity	Photopic and Mesopic	Twelve (12) Months
Other	Posterior Capsule Opacification (PCO)		Twelve (12) Months
Other	Nd:YAG rate	Incidence of Neodymium:yttrium-aluminum-garnet (Nd:YAG) laser capsulotomy as treatment for PCO	Twelve (12) Months
Other	Optimization of CZM IOL calculation tools	Anonymized Biometry raw data will be collected and used to optimize Carl ZEISS Meditec IOL calculation tools, such as the ZEISS IOL Power Calculation Service and algorithms of the optical biometer IOL Master 700, to improve future clinical outcomes.	Twelve (12) Months
Primary	Mean monocular best-corrected distance visual acuity (CDVA)	The objective is to evaluate Corrected Distance Visual Acuity (CDVA)	Three (3) Months
Secondary	Refractive Predictability / Manifest Refraction and Prediction Error	Descriptive analysis of the manifest refraction parameters sphere, cylinder, and spherical equivalent (MRSE) will be reported to determine refractive predictability	Twelve (12) Months