Investigation of the Presbia Flexivue Microlens™

NCT02110472 | Unknown Phase 3

• 1 other identifier: CLP-12-001
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 11

Brief Summary

The Presbia Flexivue Microlens is a corneal inlay.

Conditions

Presbyopia

Keywords

Emmetropic presbyopes; Presbyopic

Outcome Measures

Primary Outcomes (1)

• Uncorrected near visual acuity - operated eyes

  Uncorrected near visual acuity at 40 cm of 20/40 or better

  24 months postoperative

Secondary Outcomes (1)

• Uncorrected near visual acuity - operated eyes

  24 months postoperative

Study Arms (1)

Presbia Flexivue Microlens Corneal Inlay

OTHER

Presbia Flexivue Microlens implanted in corneal pocket in nondominant eye

Device: Corneal inlay

Interventions

Corneal inlay DEVICE

Presbia Flexivue Microlens implantation in corneal pocket created in nondominant eyes of emmetropic presbyopes.

Also known as: Presbia Flexivue Microlens, Presbia Microlens

Presbia Flexivue Microlens Corneal Inlay

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be emmetropes with presbyopia, between ≥ 45 years and ≤ 60 years of age at time of eligibility visit.
• Subjects must need a reading add of +1.50 D to +3.50 D.
• Subjects must have uncorrected near visual acuity of 20/50 or worse.
• Subjects must have near visual acuity correctable to 20/20 or better in each eye.
• Subjects must have distance visual acuity correctable to 20/25 or better in each eye.
• Subjects must have a preoperative spherical equivalent of +1.00 D to -0.75 D with no more than 0.75 D of refractive cylinder as determined by cycloplegic refraction in each eye.
• Subjects must have a photopic pupil size of \> 1.6 mm in the eye to be implanted.

You may not qualify if:

• Subjects in whom the non-dominant eye cannot be determined using one of the methods identified in the test of ocular dominance.
• Subjects who do not complete the monovision tolerance trial (minimum of 5 to 7 days).
• Subjects who report that they were not completely satisfied with their vision during the monovision tolerance trial.
• Subjects who report that they experienced debilitating or significant visual symptoms such as halos, glare, double vision, etc. during the monovision tolerance trial.
• Subjects with a difference of ≥ 1.00 D between the spherical equivalent manifest refraction and the spherical equivalent cycloplegic refraction.
• Subject with a preferred near working distance of \< 35 cm or \> 45 cm.
• Subjects with corneal thickness \< 500 microns in the eye to be implanted.
• Subjects with clinically significant anterior segment pathology, including cataracts, in either eye.
• Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any progressive corneal abnormalities (including endothelial dystrophy, guttata in the central cornea, etc.) in the eye to be treated.
• Subjects with keratoconus (or keratoconus suspect), amblyopia, recurrent erosion syndrome or corneal dystrophy in the eye to be treated.
• Subjects with a history of chronic dry eye not controlled on therapy or with superficial punctuate keratitis (SPK) grade \> II (i.e., greater than mild) based on Oxford Grading Scale in the eye to be treated.
• Subjects with abnormal corneal mires on topography maps of the eye to be treated.
• Subjects who require canthotomy to generate a corneal tunnel in the eye to be treated.
• Subjects with progressive retinal pathology with a reasonable chance of causing a reduction in BCVA from preoperative in the eye to be treated.
• Subjects who have undergone previous intraocular or corneal surgery including cataract and refractive surgery (e.g., LASIK surgery) in either eye.

Sponsors & Collaborators

• PresbiBio, LLC: lead

Study Sites (11)

Assil Eye Institute

Beverly Hills, California, 90210, United States

Location

Gordon-Weiss-Schanzlin

La Jolla, California, 92122, United States

Location

Maloney Vision Institute

Los Angeles, California, 90024, United States

Location

Stanford Eye and Laser Center

Palo Alto, California, 94303, United States

Location

Center for Sight

Sarasota, Florida, 34239, United States

Location

Kraft Eye Institute

Chicago, Illinois, 60602, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27410, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Berkeley Eye and Laser Center

Houston, Texas, 77027, United States

Location

Hoopes Vision, Laser Correction Center

Draper, Utah, 84020, United States

Location

The Eye Center

Fairfax, Virginia, 22031, United States

Location

Related Links

• Website dedicated to patient recruitment (approved by WIRB on 4/3/2014).

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Robert K Maloney, MD, MA

  Maloney Vision Institute

  STUDY DIRECTOR

• Mickey Gordon, MD

  Gordon-Weiss-Schanzlin Vision Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (11)