A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Presbyopic Subjects
NCT ID: NCT02668523
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2015-12-31
2018-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Raindrop Near Vision Inlay
To improve the near and intermediate vision in subjects who have previously undergone cataract surgery (pseudophakic subjects)
Interventions
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Raindrop Near Vision Inlay
To improve the near and intermediate vision in subjects who have previously undergone cataract surgery (pseudophakic subjects)
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
ALL
No
Sponsors
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ReVision Optics, Inc.
INDUSTRY
Responsible Party
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Locations
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Harvard Eye Associates
Laguna Hills, California, United States
Coastal Vision Laser Eye Center
Orange, California, United States
The Eye Associates of Manatee
Bradenton, Florida, United States
The Eye Institute of West Florida
Largo, Florida, United States
The Bowie Vision Institute
Bowie, Maryland, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Associated Eye Care
Stillwater, Minnesota, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Parkhurst NuVision
San Antonio, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P15-0010
Identifier Type: -
Identifier Source: org_study_id
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