Investigation of the Presbia Flexivue Microlens™
The Presbia Flexivue Microlens is a corneal inlay.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Prospective, Non-randomized, Unmasked, Multicenter Clinical Investigation of the Presbia Flexivue Microlens™ for the Improvement of Near Vision in Emmetropic Presbyopes|
- Uncorrected near visual acuity - operated eyes [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]Uncorrected near visual acuity at 40 cm of 20/40 or better
- Uncorrected near visual acuity - operated eyes [ Time Frame: 24 months postoperative ] [ Designated as safety issue: No ]
- Number of lines of improvement uncorrected near visual acuity
- Uncorrected near visual acuity at 40 cm of 20/20 or better
- Uncorrected near visual acuity at 40 cm of 20/40 or better at each implanted lens power
- Adverse Events [ Time Frame: 24 months postoperative ] [ Designated as safety issue: Yes ]
- Rate of operated eyes with best corrected distance visual acuity 20/40 or worse
- Rate of adverse events
- Change in endothelial cell count, preoperative to postoperative
- Change in contrast sensitivity at all spatial frequencies, preoperative to postoperative
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Presbia Flexivue Microlens Corneal Inlay
Presbia Flexivue Microlens implanted in corneal pocket in nondominant eye
Device: Corneal inlay
Presbia Flexivue Microlens implantation in corneal pocket created in nondominant eyes of emmetropic presbyopes.
Presbyopia is a multifactorial physiological aging mechanism that leads to a progressive functional loss of near vision. In addition to the use of reading glasses for presbyopia, a wide variety of procedures have been investigated by ophthalmologists to correct this refractive error. Cornea laser surgery with multifocal patterns or monovision approaches were developed including LASIK, PresbyLASIK, photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK), thin-flap femto-LASIK or sub-Bowman's keratomileusis (SBK). Conductive keratoplasty (CK), clear lens extraction or cataract surgery using multifocal, pseudo-accommodative intraocular lenses (IOLs) or monovision monofocal IOLs are also some of the techniques that have been used for the treatment of presbyopia.
Corneal laser surgery and CK are minimally invasive methods, but they provoke irreversible changes of the corneal anatomy, whereas scleral surgery and clear lens extraction are more invasive techniques. The necessity to develop a minimally invasive, reversible, and safe surgical technique with an easy learning curve for patients between 45 and 60 years, led to the development of refractive intracorneal lenses (inlays) (such as the AcuFocus, Inc. KAMRA™, ReVision Optics® PresbyLens®, and the Presbia Flexivue Microlens™) placed inside the corneal stroma. These inlays are refractive lenses that have a central zone free of refractive power and a peripheral zone with a standard positive refractive power. These inlays are inserted inside the corneal stroma of the non-dominant eye, generally offering two different focal points, one for the far vision and a different for the near vision respectively. The pocket of the cornea is created using a laser (details to be provided later in this protocol).
The Presbia Flexivue Microlens is intended to improve near vision and decrease dependence on reading glasses in presbyopic adults who are tolerant of monovision (as evaluated by participation in a monovision tolerance trial (5 to 7 days minimum)), who require a reading add of +1.50 D to +3.50 D, who have MRSE between +1.00 D and 0.75 D with no more than 0.75 D of refractive cylinder, and who have stable MRSE within 0.50 D over the past 12 months.
Objective: The primary objective of this study is to evaluate the safety and effectiveness of the Presbia Flexivue Microlens™ (hereinafter referred to as the "Microlens") implanted in presbyopes for improvement of near vision.
Investigational Plan: This is a prospective, non-randomized, unmasked, multicenter clinical investigation. A total of 412 subjects at up to 30 investigational sites in the United States will undergo insertion of the Microlens in non-dominant eyes, and will be followed through 36 months postoperative (assuming an estimated 10% per year lost to follow-up). Each site will contribute a targeted minimum of 10 treated subjects, but no more than 25% of the total subjects treated in the study. Data on a minimum of 300 subjects with 24 month data will be submitted as part of the Premarket Approval; all subjects will be followed through 36 months postoperative. Subjects from outside the United States will not be enrolled in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02110472
|United States, California|
|Assil Eye Institute|
|Beverly Hills, California, United States, 90210|
|La Jolla, California, United States, 92122|
|Maloney Vision Institute|
|Los Angeles, California, United States, 90024|
|United States, North Carolina|
|TLC Laser Eye Centers|
|Greensboro, North Carolina, United States, 27410|
|United States, Texas|
|Berkeley Eye and Laser Center|
|Houston, Texas, United States, 77027|
|United States, Utah|
|Hoopes Vision, Laser Correction Center|
|Draper, Utah, United States, 84020|
|Study Director:||Robert K Maloney, MD, MA||Maloney Vision Institute|