Clinical Trial on the Visual Function of Enhanced Monofocal and EDoF Intraocular Lenses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraocular lens.
- Who it may be relevant to
- Registry conditions: Cataract. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Clinical Trial to Evaluate the Visual Function of Enhanced Monofocal and Extended Depth of Field Intraocular Lenses
Overview
Randomized clinical trial to evaluate the visual performance of enhanced monofocal and extended depth-of-field intraocular lenses
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.
Interventions
- Device Intraocular lens
Implantation of intraocular lens
Primary outcome measures
- Visual acuity at different distances [Time frame: 1 month, 3 months, 6 months]
- Dysphotopsias [Time frame: 1 month, 3 months, 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07715071 · IIBSP-LEN-2024-38