Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07715071

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraocular lens

Device

Implantation of intraocular lens

Primary outcomes

  1. Visual acuity at different distances

    Time frame: 1 month, 3 months, 6 months

    Far vision, intermediate vision, near vision

  2. Dysphotopsias

    Time frame: 1 month, 3 months, 6 months

    Dysphotopsias after the IOL implantation

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.