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Clinical Performance of a Phakic Intraocular Lens (IOL)

Sponsor
Staar Surgical Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03499821
Collaborator
(none)
41
Enrollment
6
Locations
1
Arm
15.6
Actual Duration (Months)
6.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EDOF ICL
 N/A

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

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Device: Open label, all subjects receive same treatmentDevice: Open label, all subjects receive same treatment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens
Actual Study Start Date :
Mar 20, 2018
Actual Primary Completion Date :
Jul 9, 2019
Actual Study Completion Date :
Jul 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study population

EDOF ICL implanted into both eyes of eligible subjects.

Device: EDOF 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.
Other Names:
  • EVO+ Visian ICL with Aspheric (EDOF) Optic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Uncorrected Near Visual Acuity (UCNVA) [6 months]

      monocular UCNVA of Snellen equivalent 20/40 or better

    Secondary Outcome Measures

    1. UCNVA [1 and 3 months]

      monocular UCNVA of Snellen equivalent 20/40 or better

    2. Uncorrected Intermediate Visual Acuity (UCIVA) [1,3 and 6 months]

      Change from baseline in monocular UCIVA

    3. UCNVA change from baseline [1,3 and 6 months]

      Change from baseline in monocular UCNVA

    4. Distance Corrected Intermediate Visual Acuity (DCIVA) [1,3 and 6 months]

      Change from baseline in monocular DCIVA

    5. Distance Corrected Near Visual Acuity (DCNVA) [1,3 and 6 months]

      Change from baseline in monocular DCNVA

    6. Binocular UCNVA [1,3 and 6 months]

      Change from baseline in binocular UCNVA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Must be able to read, understand and provide written informed consent,

    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. Photopic pupil ≥ 3.0 mm in both eyes,

    11. Anterior chamber depth (ACD) ≥ 2.8 mm if require spherical lens powers from -0.50 D to -18.00 D,

    12. ACD ≥ 3.0 mm if require spherical lens powers from 0.00 D to +3.00 D,

    13. Anterior chamber angle ≥ Grade III,

    14. Phakic in both eyes,

    15. 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:

    16. 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,

    17. two refractions were performed at least 7 days apart.

    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. Total higher order aberrations > 0.2 µm over a 4 mm pupil,

    6. Amblyopia,

    7. Presence of active or history of chronic inflammation in either eye,

    8. Clinically significant irregular astigmatism in either eye,

    9. 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,

    10. Use of topical steroids at time of implantation,

    11. Systemic or topical medication, other than prescribed study medications that may confound the outcome or increase the risk to the subject,

    12. Allergy to anesthetics or other postoperative medications required in this study,

    13. 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,

    14. Subjects who present any emotional, physiologic, or anatomical condition which may preclude study participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mediopolis Antwerp Belgium B-2610
    2 Instituto Oftalmológico Fernández-Vega Oviedo Asturias Spain 33012
    3 Qvision-Hospital Vithas Virgen del Mar Almería Spain 04120
    4 IMO Instituto de Microcirugía Ocular Barcelona Spain 08035
    5 Innova Ocular Begitek San Sebastián Spain 20012
    6 Clínica Oftalmológica Gasteiz Vitoria-Gasteiz Spain 01005

    Sponsors and Collaborators

    • Staar Surgical Company

    Investigators

    • Study Director: Jon K Hayashida, OD, FAAO, Staar Surgical Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Staar Surgical Company
    ClinicalTrials.gov Identifier:
    NCT03499821
    Other Study ID Numbers:
    • Study CP17-01
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    Jul 20, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Presbyopia

    Study Results

    No Results Posted as of Jul 20, 2020