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CompletedNCT03499821Updated Mar 16, 2026Results posted

Clinical Performance of a Phakic Intraocular Lens (IOL)

An interventional study of EDOF ICL in Presbyopia, sponsored by Staar Surgical Company. Completed at 6 sites in 2 countries. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Staar Surgical Company · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
40 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 41 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Staar Surgical Company is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must be able to read, understand and provide written ,
  2. Willing and able to comply with all treatment and follow-up study related procedures,
  3. 40 - 60 years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
  4. 35 - 45 years of age at time of surgery if require a spherical lens power from 0.0 D to +3.00 D,
  5. Preoperative refraction fully correctable with available lens powers, with ≤ 0.75 D preoperative refractive and residual cylinder,
  6. \< 0.75 D spherical equivalent difference between cycloplegic and manifest refractions,
  7. Stable correction (± 0.50 D) as determined by manifest refraction spherical equivalent (MRSE),
  8. Best Corrected Distance Visual Acuity 20/20 or better in both eyes,
  9. Requires +1.00 D to +2.50 D reading add,
  10. Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,
  11. ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D,
  12. Anterior chamber angle ≥ Grade III,
  13. Phakic in both eyes,

  14. 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:

    1. 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,
    2. two refractions were performed at least 7 days apart.

Exclusion criteria

Exclusion Criteria:

  1. Participation in a clinical trial within 30 days prior to entry into this study and/or during the period of study participation,
  2. Previous intraocular or corneal surgery in either eye, including refractive surgery,
  3. Progressive sight threatening disease or other previous or current ocular conditions, other than myopia in either eye,
  4. Low/abnormal corneal endothelial cell density,
  5. Amblyopia,
  6. Presence of active or history of chronic inflammation in either eye,
  7. irregular astigmatism in either eye,
  8. 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,
  9. Use of topical at time of implantation,
  10. Systemic or topical medication, other than prescribed study medications that may confound the outcome or increase the risk to the subject,
  11. Allergy to anesthetics or other postoperative medications required in this study,
  12. 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,
  13. Subjects who present any emotional, physiologic, or anatomical condition which may preclude study participation.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Study population

    EDOF ICL implanted into both eyes of eligible subjects.

    Device: EDOF ICL

Interventions

  • DeviceEDOF ICL

    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.

    Also known as: EVO+ Visian ICL with Aspheric (EDOF) Optic

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 1 month

  2. 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

    Time frame: 3 months

  3. 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

    Time frame: Baseline and 1 month

  4. 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

    Time frame: Baseline and 3 months

  5. 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

    Time frame: Baseline and 6 months

  6. 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

    Time frame: Baseline and 1 month

  7. 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

    Time frame: Baseline and 3 months

  8. 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

    Time frame: Baseline and 6 months

  9. 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

    Time frame: Baseline and 1 month

  10. 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

    Time frame: Baseline and 3 months

  11. 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

    Time frame: Baseline and 6 months

  12. 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

    Time frame: Baseline and 1 month

  13. 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

    Time frame: Baseline and 3 months

  14. 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

    Time frame: Baseline and 6 months

  15. 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

    Time frame: Baseline and 1 month

  16. 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

    Time frame: Baseline and 3 months

  17. 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

    Time frame: Baseline and 6 months

07

Results

Posted Sep 21, 2022
Limitations and caveats
The study included subjects with residual accommodation. In order to further elucidate the performance of the EDOF ICL vis a vis severity of presbyopia at baseline, the performance of those eyes and subjects which not only required a reading add but also exhibited distance corrected near visual acuity of 20/40 or worse at baseline was examined. Refer to publication in reference module for more details.

Participant flow

A total of 41 subjects were screened in the study. Six did not meet eligibility and 35 subjects were treated at 6 clinical sites in Europe (5 sites in Spain and 1 site in Belgium). The first enrolled subject underwent bilateral surgery in May 2018, the last subject completed the last study visit in July 2019.

Participant flow — Overall Study
MilestoneStudy Population
Started35
Completed34
Not completed1

Outcome measures

PrimaryNumber 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

Time frame:
6 months
Reported as:
Count of units · Eyes
Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation
EyesStudy Population
Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation66
SecondaryPercentage 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

Time frame:
1 month
Reported as:
Count of units · Eyes
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation
EyesStudy Population
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation66
SecondaryPercentage 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

Time frame:
3 months
Reported as:
Count of units · Eyes
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation
EyesStudy Population
Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation66
SecondaryChange 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

Time frame:
Baseline and 1 month
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation7.63 ± 3.42
SecondaryChange 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

Time frame:
Baseline and 3 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation7.69 ± 3.48
SecondaryChange 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

Time frame:
Baseline and 6 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation7.79 ± 3.53
SecondaryChange 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

Time frame:
Baseline and 1 month
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation5.96 ± 3.9
SecondaryChange 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

Time frame:
Baseline and 3 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation5.93 ± 4.05
SecondaryChange 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

Time frame:
Baseline and 6 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation6.22 ± 3.95
SecondaryChange 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

Time frame:
Baseline and 1 month
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation.24 ± 2
SecondaryChange 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

Time frame:
Baseline and 3 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation.31 ± 2.02
SecondaryChange 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

Time frame:
Baseline and 6 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation.44 ± 2.09
SecondaryChange 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

Time frame:
Baseline and 1 month
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation1 ± 1.6
SecondaryChange 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

Time frame:
Baseline and 3 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation.92 ± 1.74
SecondaryChange 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

Time frame:
Baseline and 6 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation1.11 ± 1.62
SecondaryChange 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

Time frame:
Baseline and 1 month
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation5.95 ± 3.99
SecondaryChange 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

Time frame:
Baseline and 3 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation5.99 ± 4.01
SecondaryChange 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

Time frame:
Baseline and 6 months
Reported as:
Mean · Lines of Vision Gained
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation
Lines of Vision GainedStudy Population
Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation6.12 ± 3.96

Adverse events

Collected over 6 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Study Population0/35 (0%)9/35 (25.7%)13/35 (37.1%)
Most frequent serious events
Most frequent serious events
EventStudy Population
Visual Acuity ReducedEye disorders9/35
Vascular Migraine with AuraNervous system disorders1/35
Most frequent other events
Most frequent other events
EventStudy Population
Visual Acuity ReducedEye disorders8/35
Dry EyeEye disorders5/35
Intraocular Pressure IncreasedInvestigations3/35
Corneal OedemaEye disorders2/35
HordeolumInfections and infestations2/35
Eye PruritusEye disorders1/35
Eye InflammationEye disorders1/35
Lacrimation IncreasedEye disorders1/35
ConjunctivitisInfections and infestations1/35
Conjunctival LacerationInjury, poisoning and procedural complications1/35

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Study Population
<=18 years0
Between 18 and 65 years35
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Study Population
Female24
Male11
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Study Population
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White35
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Study Population
Belgium10
Spain25
Monocular UNVA better than 20/40 at Preoperative Visit
Monocular UNVA better than 20/40 at Preoperative Visit(Eyes)Study Population
Number15
08

Study locations

6 sites
  • Mediopolis
    Antwerp, B-2610, Belgium
  • Instituto Oftalmológico Fernández-Vega
    Oviedo, Principality of Asturias 33012, Spain
  • Qvision-Hospital Vithas Virgen del Mar
    Almería, 04120, Spain
  • IMO Instituto de Microcirugía Ocular
    Barcelona, 08035, Spain
  • Innova Ocular Begitek
    San Sebastián, 20012, Spain
  • Clínica Oftalmológica Gasteiz
    Vitoria-Gasteiz, 01005, Spain
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Jul 2019, 15 months.

Results were first posted in Sep 2022, 3 years 2 months after primary completion. A results delay was requested in Jul 2020.

Of 87 industry-sponsored interventional studies with no phase under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's 15 months is above that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2018
First posted
Apr 17, 2018
StartActual
Mar 20, 2018
Primary completionActual
Jul 9, 2019
CompletionActual
Jul 9, 2019
Results delay requested
Jul 16, 2020
Results first posted
Sep 21, 2022
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03499821
Lead sponsor
Staar Surgical Company
Responsible party
Sponsor
First posted
Apr 17, 2018
Start date
Mar 20, 2018
Primary completion
Jul 9, 2019
Completion
Jul 9, 2019
Results posted
Sep 21, 2022
Last update
Mar 16, 2026

Study contacts

Joanne Egamino, PhD
study director · Staar Surgical Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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