A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Presbyopic Subjects

January 6, 2017 updated by: ReVision Optics, Inc.

A Prospective, Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc., RAINDROP® NEAR VISION INLAY for the Improvement of Near and Intermediate Vision in Pseudophakic Subjects

The objective of this study is to evaluate the safety and effectiveness of the Raindrop Near Vision Inlay implanted in bilateral pseudophakes with presbyopia for improvement of near and intermediate vision.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The loss of near vision and the ability to perform tasks that require near vision is part of the normal aging process. This natural transformation in the eye occurs as a result of the loss of accommodation of the crystalline lens, a condition known as presbyopia. Presbyopia, characterized by a progressive, age-related loss of accommodation (i.e., the lens ability to focus clearly over a wide range of distances), is most prevalent of all visual deficiencies, affecting 100% of the population over the course of a normal life span.

Presbyopia is also a natural outcome of pseudophakic subjects with monofocal or toric intraocular lenses. Treatment of pseudophakic presbyopia generally consists of reading glasses, contact lenses, or monovision LASIK which allows the patient to see near objects. All these options present limitations from the patient perspective.

ReVision Optics has developed the Raindrop corneal inlay for the correction of near vision. The Raindrop is a 2mm corneal inlay, as small as a pinhead, thinner than a human hair and about 1/500th of a droplet of water. The inlay is the same refractive index as the human cornea. The inlay is placed in the non-dominant eye, centered over the pupil after a corneal flap or corneal pocket has been made. The Raindrop is expected to provide pseudophakic presbyopic subjects with improvement of near and intermediate vision.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • Harvard Eye Associates
        • Contact:
        • Principal Investigator:
          • John A Hovanesian, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Coastal Vision Laser Eye Center
        • Contact:
        • Principal Investigator:
          • Dan B Tran, MD
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • The Eye Associates of Manatee
        • Contact:
        • Principal Investigator:
          • Cathleen McCabe, MD
      • Largo, Florida, United States, 33770
        • Recruiting
        • The Eye Institute of West Florida
        • Contact:
        • Principal Investigator:
          • Robert Weinstock, MD
    • Maryland
      • Bowie, Maryland, United States, 20716
        • Recruiting
        • The Bowie Vision Institute
        • Contact:
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Associated Eye Care
        • Principal Investigator:
          • Stephen S Lane, MD
        • Contact:
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Recruiting
        • Cleveland Eye Clinic
        • Principal Investigator:
          • William F Wiley, MD
        • Contact:
    • South Dakota
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Key-Whitman Eye Center
        • Principal Investigator:
          • Jeffrey Whitman, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Douglas D Koch, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Parkhurst NuVision
        • Principal Investigator:
          • Gregory D Parkhurst, MD
        • Contact:
        • Sub-Investigator:
          • Arthur Medina, OD
    • Utah
      • Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must provide informed consent, have signed the written informed consent form, and been given a copy.
  2. Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add from +1.50 D to +2.50 D.
  3. Subjects must be at least 50 years old
  4. Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.
  5. Subjects must have monocular uncorrected distance visual acuity of 20/25 or better in both eyes.
  6. Subjects must have distance and near visual acuity correctable to at least 20/20 in both eyes.
  7. Subjects must have a manifest refraction spherical equivalent (MRSE) between -0.50 and +1.00 D with no more than 0.75 D of refractive cylinder in the non-dominant eye.
  8. Subjects must have a tear break-up time (TBUT) of ≥8 seconds.
  9. Subjects must have a central corneal thickness of between 480 and 600 microns in the non-dominant eye.
  10. Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.
  11. Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.
  12. Subjects must have an endothelial cell count ≥ 2200 cells/mm2 in the eye to be implanted (non-dominant).
  13. Subjects who are contact lens wearers must discontinue hard or rigid gas permeable lenses for at least 3 weeks and discontinue soft lenses for at least 1 week prior to baseline examination.
  14. Subjects who are contact lens wearers must have two (2) central keratometry readings with regular mires and two (2) manifest refractions taken at least one week apart, with no contact lens wear between. Keratometric values must not differ by more than ± 0.50 D in any meridian the eye to be implanted. MRSE values must not differ more than ±0.50 D in the non-dominant eye.
  15. Subjects must have documented monovision tolerance as determined by a 5-day contact lens trial prior to surgery.
  16. Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.
  17. Subjects must be able to demonstrate refractive stability after cataract surgery (e.g., No change in MRSE greater than ± 0.50 D within the last 2 consecutive visual examinations after IOL implantation, performed at least 3 months apart.
  18. Subjects must have a clear or open posterior capsule in the non-dominant eye.
  19. Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.

Exclusion Criteria:

  1. Subjects with anterior chamber or multifocal IOLs (intraocular lens) in either eye.
  2. Subjects with clinically significant anterior segment pathology in either eye.
  3. Subjects who have worn soft or rigid contact lenses within the past 30 days in the eye to be treated (excludes the contact lens trial for monovision tolerance).
  4. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease (e.g., meibomian gland dysfunction), or any corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in either eye.
  5. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in either eye.
  6. Subjects with distorted or unclear corneal mires on topography maps of the non- dominant eye.
  7. Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.
  8. Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in either eye.
  9. Subjects who have undergone previous corneal surgery including LASIK surgery in the non-dominant eye.
  10. Subjects with a history of ocular herpes zoster or ocular herpes simplex keratitis.
  11. Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mm Hg, glaucoma, or who are a glaucoma suspect in either eye.
  12. Subjects with a history of uncontrolled diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
  13. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
  14. Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology excluding ocular allergy.
  15. Subjects using systemic medications with significant ocular side effects.
  16. Subjects with known sensitivity to planned study concomitant medications.
  17. Subjects who are participating in any other clinical trial during the course of this clinical investigation.
  18. Subjects who have had previous astigmatic keratotomy or limbal relaxing incisions at the time of cataract surgery.
  19. Subjects who are of child bearing potential and who have a positive pregnancy test result, prior to surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Raindrop
A single arm study to evaluate the effectiveness of a 2mm Raindrop Near Vision Inlay for the treatment of presbyopia in pseudophakic subjects. This corneal inlay is placed under a LASIK flap or in a corneal pocket, and is designed to change the anterior curvature of the cornea, resulting in the ability to reduce spectacle dependency for near and intermediate tasks.
Device: Raindrop Near Vision Inlay
To improve the near and intermediate vision in subjects who have previously undergone cataract surgery (pseudophakic subjects)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in uncorrected near visual acuity
Time Frame: 24 Months
Seventy-five percent of eyes should achieve uncorrected near visual acuity of 20/40 or better.
24 Months
Preservation of best corrected visual acuity
Time Frame: 24 Months
Fewer than five percent of eyes should lose more than 2 lines of best corrected distance visual acuity after implantation
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in uncorrected intermediate visual acuity
Time Frame: 24 Months
Seventy-five percent of eyes should achieve uncorrected intermediate visual acuity of 20/40 or better (measured at 80cm/32 inches)
24 Months
Adverse Events
Time Frame: 24 Months
Adverse events should occur in less than 10% of eyes and any single adverse event should occur in less than 2.5% of eyes.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReVision Optics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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