Clinical trial NCT01373580: A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: presbyopia
LASIK
loss of accommodation
Emmetrope
Lead sponsor: ReVision Optics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 373
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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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Primary outcomes:
measure: Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye
timeFrame: 24 Months
Secondary outcomes:
measure: Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye
timeFrame: at 6 months postoperative and all subsequent visits
measure: Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye
timeFrame: At 6 months postoperative and all subsequent visits
Other outcomes:
Locations:
city: Camarillo
country: United States
facility: Dougherty Laser Vision
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Newport Beach
country: United States
facility: Coastal Vision
state: California
city: Greenwood Village
country: United States
facility: Jon G. Dishler, M.D.
state: Colorado
city: Honolulu
country: United States
facility: Eyesight Hawaai
state: Hawaii
city: Bloomington
country: United States
facility: Chu Vision
state: Minnesota
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Dallas
country: United States
facility: Carter Eye Center
state: Texas
city: Houston
country: United States
facility: Slade and Baker Vision Center
state: Texas
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
city: San Antonio
country: United States
facility: NuVision.
state: Texas
Study officials:
name: Steven G Slade, M.D.
role: PRINCIPAL_INVESTIGATOR
name: Jon G Dishler, MD
role: PRINCIPAL_INVESTIGATOR
name: John Olkowski, M.D.
role: PRINCIPAL_INVESTIGATOR
name: Dan B Tran, M.D.
role: PRINCIPAL_INVESTIGATOR
name: Ralph Y Chu, M.D.
role: PRINCIPAL_INVESTIGATOR
name: Jeffrey Whitman, M.D.
role: PRINCIPAL_INVESTIGATOR
name: Robert P Lehmann, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unaffilliated
name: Gregory Parkhurst, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Unaffilliated
name: Harvey L Carter, III, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unaffilliated
name: Paul Dougherty, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unaffilliated
name: John Hovanesian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitman J, Dougherty PJ, Parkhurst GD, Olkowski J, Slade SG, Hovanesian J, Chu R, Dishler J, Tran DB, Lehmann R, Carter H, Steinert RF, Koch DD. Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes. Ophthalmology. 2016 Mar;123(3):466-75. doi: 10.1016/j.ophtha.2015.11.011. Epub 2016 Jan 27.