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Clinical Performance of a Phakic Intraocular Lens (IOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499821
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Staar Surgical Company

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE March 20, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
Uncorrected Near Visual Acuity (UCNVA) [ Time Frame: 6 months ]
monocular UCNVA of Snellen equivalent 20/40 or better
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03499821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • UCNVA [ Time Frame: 1 and 3 months ]
    monocular UCNVA of Snellen equivalent 20/40 or better
  • Uncorrected Intermediate Visual Acuity (UCIVA) [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular UCIVA
  • UCNVA change from baseline [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular UCNVA
  • Distance Corrected Intermediate Visual Acuity (DCIVA) [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular DCIVA
  • Distance Corrected Near Visual Acuity (DCNVA) [ Time Frame: 1,3 and 6 months ]
    Change from baseline in monocular DCNVA
  • Binocular UCNVA [ Time Frame: 1,3 and 6 months ]
    Change from baseline in binocular UCNVA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Performance of a Phakic Intraocular Lens (IOL)
Official Title  ICMJE A Multicenter Clinical Evaluation of the Clinical Performance of a Phakic Intraocular Lens
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Device: Open label, all subjects receive same treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Presbyopia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Study population
EDOF ICL implanted into both eyes of eligible subjects.
Intervention: Device: EDOF ICL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Spain
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03499821
Other Study ID Numbers  ICMJE Study CP17-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Staar Surgical Company
Study Sponsor  ICMJE Staar Surgical Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jon K Hayashida, OD, FAAO Staar Surgical Company
PRS Account Staar Surgical Company
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP