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Not yet recruitingNCT07715071Updated Jul 20, 2026

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

An interventional study of Intraocular lens in Cataract, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Not yet recruiting. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cataract

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Keywords

  • Intraocular lens
  • Cataract
  • Enhanced monfocoal IOL
  • EDoF IOL
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 90 is above the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Group 1: Implantation of the Clareon Vivity intraocular lens

    EDoF IOL

    Device: Intraocular lens

  • Experimental
    Group 2: Implantation of the TECNIS Eyhance intraocular lens

    Enhanced monofocal IOL

    Device: Intraocular lens

  • Experimental
    Group 3: Implantation of the RayOne EMV intraocular lens

    Enhanced monofocal IOL

    Device: Intraocular lens

  • Experimental
    Group 4: Implantation of the IsoPure Serenity intraocular lens

    Enhanced monofocal IOL

    Device: Intraocular lens

  • Experimental
    Group 5: Implantation of the Vivinex Impress intraocular lens

    Enhanced monofocal IOL

    Device: Intraocular lens

  • Experimental
    Group 6: Implantation of the TECNIS PureSee intraocular lens

    EDoF IOL

    Device: Intraocular lens

Interventions

  • DeviceIntraocular lens

    Implantation of intraocular lens

06

What researchers measure

Primary outcomes

  1. Visual acuity at different distances

    Far vision, intermediate vision, near vision

    Time frame: 1 month, 3 months, 6 months

  2. Dysphotopsias

    Dysphotopsias after the IOL implantation

    Time frame: 1 month, 3 months, 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 6 months is below that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Jul 20, 2026
StartEst.
Sep 21, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Mar 31, 2027
Last update
Jul 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07715071
Responsible party
Sponsor
First posted
Jul 20, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Jul 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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