PresbyopiaNCT03499821
Clinical Performance of a Phakic Intraocular Lens (IOL)
A study testing EDOF ICL in people with Presbyopia, run by Staar Surgical Company at 6 sites in 2 countries.
Trial summary
This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- EDOF ICL
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Mar 2018to 9 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be able to read, understand and provide written informed consent,
- Willing and able to comply with all treatment and follow-up study related procedures,
- 40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
- 35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
- Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
- < 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
Show all 16Show fewer
- Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
- Best Corrected Distance Visual Acuity 20/20 or better in both eyes,
- Requires +1.00 D to +2.50 D reading add,
- Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,
- ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D,
- Anterior chamber angle ≥ Grade III,
- Phakic in both eyes,
- Current contact lens wearers need to demonstrate a stable refraction, (± 0.5 D), expressed as MRSE, on two consecutive examination dates with refractive stability determined by the following criteria:
- contact lenses were not worn for at least 2 weeks (rigid and toric contact lenses) or 3 days (soft contact lenses) prior to the first refraction,
- two refractions were performed at least 7 days apart.
Who cannot join
- Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation,
- Previous intraocular or corneal surgery in either eye, including refractive surgery,
- Progressive sight threatening disease or other previous or current ocular conditions, other than myopia in either eye,
- Low/abnormal corneal endothelial cell density,
- Amblyopia,
- Presence of active or history of chronic inflammation in either eye,
Show all 13Show fewer
- Clinically significant irregular astigmatism in either eye,
- Serious, acute, chronic or systemic, non-ophthalmic disease or illness that would increase the operative risk, confound the outcome(s) of the study or which may preclude study completion,
- Use of topical steroids at time of implantation,
- Systemic or topical medication, other than prescribed study medications that may confound the outcome or increase the risk to the subject,
- Allergy to anesthetics or other postoperative medications required in this study,
- Subject who is pregnant, plans to become pregnant, or is lactating during the course of the study, or has another condition associated with the fluctuation of hormones that could lead to refractive changes,
- Subjects who present any emotional, physiologic, or anatomical condition which may preclude study participation.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain5 sites
Qvision-Hospital Vithas Virgen del Mar
Almería, 04120
IMO Instituto de Microcirugía Ocular
Barcelona, 08035
Instituto Oftalmológico Fernández-Vega
Oviedo, Principality of Asturias, 33012
Innova Ocular Begitek
San Sebastián, 20012
Clínica Oftalmológica Gasteiz
Vitoria-Gasteiz, 01005
About this study
Official title: A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens
This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.
Read the detailed description
This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic [EDOF ICL] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add.
Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery.
The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance.
The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.
- Conditions
- Presbyopia
- Being tested
- EDOF ICL
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDOF ICLDevice
Also called EVO+ Visian ICL with Aspheric (EDOF) Optic
The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | EDOF ICL implanted into both eyes of eligible subjects. Receives: Device: EDOF ICL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation
Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation
Measured: 6 months
Secondary outcomes (17)
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation
Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 1 month after implantation
Measured: 1 month
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation
Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 3 months after implantation
Measured: 3 months
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation
Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 1 month post implantation
Measured: Baseline and 1 month
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation
Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 3 months post implantation
Measured: Baseline and 3 months
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation
Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 6 months post implantation
Measured: Baseline and 6 months
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation
Measured: Baseline and 1 month
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation
Measured: Baseline and 3 months
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 6 months post implantation
Measured: Baseline and 6 months
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation
Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 1 month post implantation
Measured: Baseline and 1 month
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation
Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 3 months post implantation
Measured: Baseline and 3 months
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation
Change from baseline in Monocular Distance corrected intermediate visual acuity (DCIVA) at 80 cm 6 months post implantation
Measured: Baseline and 6 months
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 1 month post implantation
Measured: Baseline and 1 month
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 3 months post implantation
Measured: Baseline and 3 months
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 6 months post implantation
Measured: Baseline and 6 months
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation
Measured: Baseline and 1 month
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation
Measured: Baseline and 3 months
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Change from baseline in Binocular Uncorrected Near Visual Acuity (UCNVA) at 40 cm 6 months post implantation
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start20 Mar 2018
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Device: Open label, all subjects receive same treatment
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Staar Surgical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Egamino, PhD, Study director, Staar Surgical Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499821
- Sponsor's protocol ID
- Study CP17-01
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2018
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Packer M, Alfonso JF, Aramberri J, Elies D, Fernandez J, Mertens E. Performance and Safety of the Extended Depth of Focus Implantable Collamer(R) Lens (EDOF ICL) in Phakic Subjects with Presbyopia. Clin Ophthalmol. 2020 Sep 18;14:2717-2730. doi: 10.2147/OPTH.S271858. eCollection 2020.
PubMed 32982164
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens
- ClinicalTrials.gov ID
- NCT03499821
- Acronym / sponsor ID
- Study CP17-01
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Staar Surgical CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00 and +2.50 Reading Add.
Detailed description
This is a prospective, open-labeled, multi-site evaluation of clinical performance of the STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic [EDOF ICL] for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add.
Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL implantation in both eyes. All eyes will be followed for 6 months after surgery.
The first eye implanted with the study lens and the appropriate time for fellow eye implantation will be determined by the medical judgement of the Investigator. All eyes will be analyzed for safety and performance.
The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater than 75% of implanted eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: Open label, all subjects receive same treatment
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Device: EDOF ICLEDOF ICL implanted into both eyes of eligible subjects. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Must be able to read, understand and provide written informed consent,
- Willing and able to comply with all treatment and follow-up study related procedures,
- 40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
- 35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
- Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
Key exclusion criteria (13 listed)
- Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation,
- Previous intraocular or corneal surgery in either eye, including refractive surgery,
- Progressive sight threatening disease or other previous or current ocular conditions, other than myopia in either eye,
- Low/abnormal corneal endothelial cell density,
- Amblyopia,
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 |
|---|---|---|
| EDOF ICLAlso: EVO+ Visian ICL with Aspheric (EDOF) OpticThe Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction. | Device | Study population |
Primary outcome
Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation
Time frame: 6 months
Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation
17 secondary outcomes
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation
Time frame: 1 month
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation
Time frame: 3 months
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation
Time frame: Baseline and 1 month
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation
Time frame: Baseline and 3 months
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation
Time frame: Baseline and 6 months
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Time frame: Baseline and 1 month
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Time frame: Baseline and 3 months
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Time frame: Baseline and 6 months
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation
Time frame: Baseline and 1 month
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation
Time frame: Baseline and 3 months
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation
Time frame: Baseline and 6 months
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Time frame: Baseline and 1 month
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Time frame: Baseline and 3 months
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Time frame: Baseline and 6 months
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Time frame: Baseline and 1 month
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Time frame: Baseline and 3 months
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32982164Packer M, Alfonso JF, Aramberri J, Elies D, Fernandez J, Mertens E. Performance and Safety of the Extended Depth of Focus Implantable Collamer(R) Lens (EDOF ICL) in Phakic Subjects with Presbyopia. Clin Ophthalmol. 2020 Sep 18;14:2717-2730. doi: 10.2147/OPTH.S271858. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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. This study is not recruiting at the moment.
Joanne Egamino, PhD study director
Staar Surgical Company
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDOF ICL in people with Presbyopia, run by Staar Surgical Company at 6 sites in 2 countries.
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 16 inclusion and 13 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: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499821, which also lists 1 linked publication.
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 16 Mar 2026.