A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ReVision Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01373580
First received: June 13, 2011
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.


Condition Intervention Phase
Presbyopia
Device: The Raindrop Corneal Inlay
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multinational Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc. PresbyLens Corneal Inlay for the Improvement of Near Vision in Presbyopic Subjects With MRSE From -0.50 to +1.00

Further study details as provided by ReVision Optics, Inc.:

Primary Outcome Measures:
  • Improvement in uncorrected near visual acuity [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    75% of eyes should achieve uncorrected near visual acuity of 20/40 or better


Enrollment: 373
Study Start Date: April 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corneal inlay for the treatment of presbyopia
A single arm study to evaluate the effectiveness of a 2mm corneal inlay for the treatment of presbyopia. This inlay is placed under a LASIK flap, designed to change the anterior curvature of the cornea resulting in the ability to reduce spectacle dependency for near tasks.
Device: The Raindrop Corneal Inlay
Other Name: Presbylens

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. Loss of accommodation begins early in life and, for an emmetropic eye, generally culminates in a complete loss of functional near vision.

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 (LASIK)has been made. The Raindrop is expected to provide presbyopic subjects with improvement of near and intermediate vision.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

must be presbyopic adults, needing from +1.50 to +2.50 or reading add must have uncorrected near visual acuity worse than 20/40 and better than 20/200in the eye to be implanted must have an uncorrected distance visual acuity of 20/25 or better in both eyes must have a distance visual acuity correctable to 20/20 in both eyes must have a near visual acuity correctable to 20/20 in both eyes must have a manifest refraction spherical equivalent between -0.50 and +1.00D in the eye to be implanted with no more than 0.75D of refractive cylinder must report stable vision, i.e. no change in distance vision and or MRSE within 0.50D over prior 12 months 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 must have a minimum central corneal thickness of >500 microns in the eye to be implanted must have a mesopic pupil < 7.0mm and photopic pupil >3.0mm in the eye to be implanted subjects aged 45 years or younger must have an endothelial cell count

Exclusion Criteria:

Subjects with a difference of >0.75 between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent Subjects with anterior segment pathology, including clinically significant cataracts, in the non-dominant eye Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the non-dominant eye Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the non-dominant eye Subjects with clinically significant dry eyes, as determined by either the presence of greater than mild symptoms of dryness or discomfort or SPK greater than grade 1 Subjects with distorted or unclear mires on topography maps of the non-dominant eye Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the non-dominant eye Subjects who have undergone LASIK surgery in the non-dominant eye Subjects with a history of herpes zoster or herpes simplex keratitis Subjects who have a history of steroid responsive rise in intraocular pressure, pre-operative IOP>21 mm Hg, glaucoma or are a glaucoma suspect Subjects with a history of diagnosed diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects Subjects who are using ophthalmic mediation(s) other than artificial tears for treatment of any ocular pathology Subjects using systemic medications with significant ocular side effects Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study Subjects what are participating in any other ophthalmic drug or device studies during the time of this clinical investigation Subjects with known sensitivity to planned study concomitant medications

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373580

Locations
United States, California
Dougherty Laser Vision
Camarillo, California, United States, 93010
Harvard Eye Associates
Laguna Hills, California, United States, 92653
Coastal Vision
Newport Beach,, California, United States, 92660
United States, Colorado
Jon G. Dishler, M.D.
Greenwood Village, Colorado, United States, 80111
United States, Hawaii
Eyesight Hawaai
Honolulu, Hawaii, United States, 96816
United States, Minnesota
Chu Vision
Bloomington, Minnesota, United States, 55420
United States, Texas
Carter Eye Center
Dallas, Texas, United States, 75205
Key-Whitman Eye Center
Dallas, Texas, United States, 75204
Slade and Baker Vision Center
Houston, Texas, United States, 77027
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965
NuVision.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ReVision Optics, Inc.
Investigators
Principal Investigator: Steven G Slade, M.D.
Principal Investigator: Jon G Dishler, MD
Principal Investigator: John Olkowski, M.D.
Principal Investigator: Dan B Tran, M.D.
Principal Investigator: Ralph Y Chu, M.D.
Principal Investigator: Jeffrey Whitman, M.D.
Principal Investigator: Robert P Lehmann, M.D.
Principal Investigator: Gregory Parkhurst, M.D Unaffilliated
Principal Investigator: Harvey L Carter, III, M.D. Unaffilliated
Principal Investigator: Paul Dougherty, M.D. Unaffilliated
Principal Investigator: John Hovanesian, M.D. Unaffilliated
  More Information

No publications provided

Responsible Party: ReVision Optics, Inc.
ClinicalTrials.gov Identifier: NCT01373580     History of Changes
Other Study ID Numbers: P09-0003
Study First Received: June 13, 2011
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ReVision Optics, Inc.:
presbyopia
LASIK
loss of accommodation
Emmetrope

Additional relevant MeSH terms:
Presbyopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on October 23, 2014