Clinical Performance of a Phakic Intraocular Lens (IOL)

NCT03499821 | Completed Results FDA Device

• 1 other identifier: Study CP17-01
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Presbyopia

Outcome Measures

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

  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

  1 month

• Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation

  3 months

• Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation

  Baseline and 1 month

• Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation

  Baseline and 3 months

• Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation

  Baseline and 6 months

Study Arms (1)

Study population

EXPERIMENTAL

EDOF ICL implanted into both eyes of eligible subjects.

Device: EDOF ICL

Interventions

EDOF ICL DEVICE

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

Study population

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,
• years of age at time of surgery if require spherical lens powers from -0.50 D to -18.00 D,
• 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,
• 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,

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Staar Surgical Company: lead

Study Sites (6)

Mediopolis

Antwerp, B-2610, Belgium

Location

Instituto Oftalmológico Fernández-Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Qvision-Hospital Vithas Virgen del Mar

Almería, 04120, Spain

Location

IMO Instituto de Microcirugía Ocular

Barcelona, 08035, Spain

Location

Innova Ocular Begitek

San Sebastián, 20012, Spain

Location

Clínica Oftalmológica Gasteiz

Vitoria-Gasteiz, 01005, Spain

Location

Related Publications (1)

• 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.

  PMID: 32982164 RESULT

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

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.

Results Point of Contact

• Title: Joanne Egamino
• Organization: STAAR Surgical

jegamino@staar.com

626-303-7902

Study Officials

• Joanne Egamino, PhD

  Staar Surgical Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Device: Open label, all subjects receive same treatment

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: March 20, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: March 16, 2026
• Results First Posted: September 21, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); BE (1)