CataractNCT07715071
Clinical Trial on the Visual Function of Enhanced Monofocal and EDoF Intraocular Lenses
A study testing Intraocular lens in people with Cataract, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Randomized clinical trial to evaluate the visual performance of enhanced monofocal and extended depth-of-field intraocular lenses Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
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.
- Conditions
- Cataract
- Being tested
- Intraocular lens
- Keywords
- Intraocular lens, Cataract, Enhanced monfocoal IOL, EDoF IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Implantation of intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Implantation of the Clareon Vivity intraocular lens | Experimental | EDoF IOL Receives: Device: Intraocular lens |
| Group 2: Implantation of the TECNIS Eyhance intraocular lens | Experimental | Enhanced monofocal IOL Receives: Device: Intraocular lens |
| Group 3: Implantation of the RayOne EMV intraocular lens | Experimental | Enhanced monofocal IOL Receives: Device: Intraocular lens |
| Group 4: Implantation of the IsoPure Serenity intraocular lens | Experimental | Enhanced monofocal IOL Receives: Device: Intraocular lens |
| Group 5: Implantation of the Vivinex Impress intraocular lens | Experimental | Enhanced monofocal IOL Receives: Device: Intraocular lens |
| Group 6: Implantation of the TECNIS PureSee intraocular lens | Experimental | EDoF IOL Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity at different distances
Far vision, intermediate vision, near vision
Measured: 1 month, 3 months, 6 months
Dysphotopsias
Dysphotopsias after the IOL implantation
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715071
- Sponsor's protocol ID
- IIBSP-LEN-2024-38
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Visual Function of Enhanced Monofocal and Extended Depth of Field Intraocular Lenses
- ClinicalTrials.gov ID
- NCT07715071
- Acronym / sponsor ID
- IIBSP-LEN-2024-38
- Conditions
- Cataract
- Keywords
- Intraocular lens, Cataract, Enhanced monfocoal IOL, EDoF IOL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Implantation of the Clareon Vivity intraocular lens | Experimental | Device: Intraocular lensEDoF IOL |
| Group 2: Implantation of the TECNIS Eyhance intraocular lens | Experimental | Device: Intraocular lensEnhanced monofocal IOL |
| Group 3: Implantation of the RayOne EMV intraocular lens | Experimental | Device: Intraocular lensEnhanced monofocal IOL |
| Group 4: Implantation of the IsoPure Serenity intraocular lens | Experimental | Device: Intraocular lensEnhanced monofocal IOL |
| Group 5: Implantation of the Vivinex Impress intraocular lens | Experimental | Device: Intraocular lensEnhanced monofocal IOL |
| Group 6: Implantation of the TECNIS PureSee intraocular lens | Experimental | Device: Intraocular lensEDoF IOL |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular lensImplantation of intraocular lens | Device | Group 1: Implantation of the Clareon Vivity intraocular lens, Group 2: Implantation of the TECNIS Eyhance intraocular lens, Group 3: Implantation of the RayOne EMV intraocular lens, Group 4: Implantation of the IsoPure Serenity intraocular lens, Group 5: Implantation of the Vivinex Impress intraocular lens, Group 6: Implantation of the TECNIS PureSee intraocular lens |
Primary outcome
Visual acuity at different distances
Time frame: 1 month, 3 months, 6 months
Far vision, intermediate vision, near vision
Dysphotopsias
Time frame: 1 month, 3 months, 6 months
Dysphotopsias after the IOL implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens in people with Cataract, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity at different distances (time frame: 1 month, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.