- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017612
A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
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
Study Overview
Detailed Description
Presbyopia is 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 suffer limitations from the patient perspective. For example, reading glasses can easily be lost or not conveniently available. Multifocal contact lenses suffer from visual symptoms and instability due to potential rotation and movement of the contact lenses on the surface of the cornea. And, successful monovision is generally limited to patients with a history of successful use of contact lenses for monovision, and even in these eyes, monovision is associated with a substantial decrease in stereo acuity and contrast sensitivity.
ReVision Optics has developed the Raindrop Near Vision Inlay for the correction of near and intermediate vision. 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 Near Vision Inlay is expected to provide low induction of visual symptoms and improvement of near and intermediate vision in emmetropic subjects with presbyopia. This technology may also demonstrate potential clinical utility in bilateral pseudophakic subjects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Laguna Hills, California, United States, 92653
- Harvard Eye Associates
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Orange, California, United States, 92868
- Coastal Vision
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Minnesota
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Bloomington, Minnesota, United States, 55420
- Chu Vision Institute
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Texas
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Dallas, Texas, United States, 75204
- Key-Whitman Eye Center
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Dallas, Texas, United States, 75205
- Carter Eye Center
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San Antonio, Texas, United States, 78229
- Parkhurst-NuVision
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must provide informed consent, have signed the written informed consent form, and been given a copy.
- Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add from +1.50 D to +2.50 D.
- Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.
- Subjects must have an uncorrected distance visual acuity of 20/25 or better in both eyes.
- Subjects must have distance and near visual acuity correctable to at least 20/20 in both eyes.
- 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.
- Subjects must have a tear break-up time (TBUT) of ≥8 seconds.
- Subjects must have a central corneal thickness of between 500 and 600 microns in the non-dominant eye.
- Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.
- Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.
- Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the non-dominant eye.
- Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.
- Subjects must have documented monovision tolerance.
- Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.
- 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 visits at least 2 months apart) in the non-dominant eye.
- Subjects must have a clear or open posterior capsule in the non-dominant eye. -
Exclusion Criteria:
1. Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or multifocal intraocular lenses (IOLs) in either eye.
2. Subjects with 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.
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 herpes zoster or herpes simplex keratitis.
11. Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mm Hg, glaucoma, or 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.
Study Plan
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 |
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Experimental: Single Arm Study
Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects
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A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss).
The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision
Time Frame: 12 months postoperatively
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75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better
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12 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preservation of Best Corrected Visual Acuity
Time Frame: at 6 months postoperatively and all subsequent time points up to 24 months
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Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40
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at 6 months postoperatively and all subsequent time points up to 24 months
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Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D
Time Frame: At 6 months postoperatively and all subsequent time points up to 24 months
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Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D
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At 6 months postoperatively and all subsequent time points up to 24 months
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Occurrence of Adverse Events
Time Frame: During the length of the study, up to 24 months
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Any specific adverse event should occur in less than or equal to 5% of eyes.
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During the length of the study, up to 24 months
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Uncorrected Intermediate Visual Acuity
Time Frame: at 12 months postoperatively
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75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
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at 12 months postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Roger Steinert, MD, Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P13-0064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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