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Clinical Performance of a Phakic Intraocular Lens (IOL)

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ClinicalTrials.gov Identifier: NCT03499821
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Staar Surgical Company

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
Presbyopia Device: EDOF ICL Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Device: 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 : March 20, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : March 30, 2019

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 Name: EVO+ Visian ICL with Aspheric (EDOF) Optic




Primary Outcome Measures :
  1. Uncorrected Near Visual Acuity (UCNVA) [ Time Frame: 6 months ]
    monocular UCNVA of Snellen equivalent 20/40 or better


Secondary Outcome Measures :
  1. UCNVA [ Time Frame: 1 and 3 months ]
    monocular UCNVA of Snellen equivalent 20/40 or better

  2. Uncorrected Intermediate Visual Acuity (UCIVA) [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular UCIVA

  3. UCNVA change from baseline [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular UCNVA

  4. Distance Corrected Intermediate Visual Acuity (DCIVA) [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular DCIVA

  5. Distance Corrected Near Visual Acuity (DCNVA) [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular DCNVA

  6. Binocular UCNVA [ Time Frame: 1,3 and 6 months ]
    Change from baseline in binocular UCNVA



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

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:

    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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499821


Contacts
Contact: Global Head of Clinical Operations 5852785839 jegamino@staar.com
Contact: Kevin Pohlemann, PhD +49 (0)421 89 67 66 24 kpoehlmann@gcp-service.com

Locations
Belgium
Mediopolis Recruiting
Antwerp, Belgium, B-2610
Contact: Werner Ingels    +32038 28 29 49    w.ingels@medipolis.be   
Principal Investigator: Erik L Mertens, MD         
Spain
Instituto Oftalmológico Fernández-Vega Recruiting
Oviedo, Asturias, Spain, 33012
Contact: Gloria de la Torre    +34 985 24 01 41    gloria.torre@fernandez-vega.com   
Principal Investigator: Jose Alfonso, MD         
Qvision-Hospital Vithas Virgen del Mar Recruiting
Almería, Spain, 04120
Contact: Manuel Rodríguez Vallejo       manuelrodriguezid@qvision.es   
Principal Investigator: Joaquin Fernández, MD         
IMO Instituto de Microcirugía Ocular Recruiting
Barcelona, Spain, 08035
Contact: Laura Gonzalez    +34 253 15 00 ext 1704    gonzalez@imo.es   
Principal Investigator: Daniel Elies, MD         
Innova Ocular Begitek Recruiting
San Sebastián, Spain, 20012
Contact: Igor Illaramedio, OD    +34 616 94 15 58    illarra2002@yahoo.es   
Principal Investigator: Jaime Aramberri, MD         
Clínica Oftalmológica Gasteiz Recruiting
Vitoria-Gasteiz, Spain, 01005
Contact: Paula Rosello, OD    +34 616 94 15 58    prosello13@gmail.com   
Principal Investigator: Jaime Aramberri, MD         
Sponsors and Collaborators
Staar Surgical Company
Investigators
Study Director: Jon K Hayashida, OD, FAAO Staar Surgical Company

Responsible Party: Staar Surgical Company
ClinicalTrials.gov Identifier: NCT03499821     History of Changes
Other Study ID Numbers: Study CP17-01
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases