Clinical Trial on the Visual Function of Enhanced Monofocal and EDoF Intraocular Lenses

July 15, 2026 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Randomized Clinical Trial to Evaluate the Visual Function of Enhanced Monofocal and Extended Depth of Field Intraocular Lenses

Randomized clinical trial to evaluate the visual performance of enhanced monofocal and extended depth-of-field intraocular lenses

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective

To evaluate whether the implantation of enhanced monofocal intraocular lenses during cataract surgery results in fewer adverse visual phenomena (dysphotopsias) than the implantation of extended depth-of-field (EDoF) intraocular lenses.

Secondary Objectives

To evaluate whether there are differences in best-corrected visual acuity at various distances, contrast sensitivity, visual quality, and quality of life between patients implanted with enhanced monofocal intraocular lenses and those implanted with extended depth-of-field intraocular lenses.

To evaluate whether there are differences in best-corrected visual acuity at various distances, contrast sensitivity, visual quality, and quality of life among the four enhanced monofocal intraocular lenses analyzed in the present study.

To evaluate whether there are differences in best-corrected visual acuity at various distances, contrast sensitivity, visual quality, and quality of life between the two extended depth-of-field intraocular lenses analyzed in the present study.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  • Patients with bilateral cataracts at different stages of development.
  • Patients with functional visual demands.
  • Age between 45 and 80 years.
  • Male or female sex.
  • Ability to provide informed consent.

EXCLUSION CRITERIA:

Preoperative Exclusion Criteria

• Medical criteria:

Corneal astigmatism greater than 1.0 diopter. Pre-existing ocular pathology. Previous refractive surgery. Previous corneal or intraocular implant. Poor general health status or potentially reduced neuroadaptation capacity due to previous stroke, Alzheimer's disease, other forms of dementia, etc.

Unrealistic postoperative visual expectations.

Intraoperative Withdrawal Criteria

  • Vitreous loss.
  • Pupillary trauma.
  • Factors likely to affect the medium-term performance of the intraocular lens: Zonular damage, Capsulorhexis tear or injury, Capsular rupture, Endothelial damage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Implantation of the Clareon Vivity intraocular lens
EDoF IOL
Device: Intraocular lens
Implantation of intraocular lens
Experimental: Group 2: Implantation of the TECNIS Eyhance intraocular lens
Enhanced monofocal IOL
Device: Intraocular lens
Implantation of intraocular lens
Experimental: Group 3: Implantation of the RayOne EMV intraocular lens
Enhanced monofocal IOL
Device: Intraocular lens
Implantation of intraocular lens
Experimental: Group 4: Implantation of the IsoPure Serenity intraocular lens
Enhanced monofocal IOL
Device: Intraocular lens
Implantation of intraocular lens
Experimental: Group 5: Implantation of the Vivinex Impress intraocular lens
Enhanced monofocal IOL
Device: Intraocular lens
Implantation of intraocular lens
Experimental: Group 6: Implantation of the TECNIS PureSee intraocular lens
EDoF IOL
Device: Intraocular lens
Implantation of intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity at different distances
Time Frame: 1 month, 3 months, 6 months
Far vision, intermediate vision, near vision
1 month, 3 months, 6 months
Dysphotopsias
Time Frame: 1 month, 3 months, 6 months
Dysphotopsias after the IOL implantation
1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 21, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-LEN-2024-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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