Randomized Clinical Trial to Evaluate the Visual Function of Enhanced Monofocal and Extended Depth of Field Intraocular Lenses
| Registry | NCT07715071 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other) |
| Conditions | Cataract |
| Interventions | Intraocular lens (Device) |
| Dates | start 2026-09-21 (estimated), primary completion 2027-03-31 (estimated), completion 2027-03-31 (estimated), first posted 2026-07-20, last updated 2026-07-20 |
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All trials for Cataract All trials of Intraocular lens
Randomized clinical trial to evaluate the visual performance of enhanced monofocal and extended depth-of-field intraocular lenses
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1: Implantation of the Clareon Vivity intraocular lens | Experimental | Device: Intraocular lens | EDoF IOL |
| Group 2: Implantation of the TECNIS Eyhance intraocular lens | Experimental | Device: Intraocular lens | Enhanced monofocal IOL |
| Group 3: Implantation of the RayOne EMV intraocular lens | Experimental | Device: Intraocular lens | Enhanced monofocal IOL |
| Group 4: Implantation of the IsoPure Serenity intraocular lens | Experimental | Device: Intraocular lens | Enhanced monofocal IOL |
| Group 5: Implantation of the Vivinex Impress intraocular lens | Experimental | Device: Intraocular lens | Enhanced monofocal IOL |
| Group 6: Implantation of the TECNIS PureSee intraocular lens | Experimental | Device: Intraocular lens | EDoF IOL |
Sex: All, ages: 45 Years to 80 Years
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.