A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects

Study Overview
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Brief Summary
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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. The ReVision Optics corneal inlay is a 2.0-mm, 30-micron inlay made of a hydrogel material, implanted under a lasik flap. Subjects must require reading add from +1.50 D to +2.50 D. Subjects must have a preoperative manifest refraction spherical equivalent of -0.50 to +1.00 D with no more than 0.75 D of refractive cylinder. The Raindrop Near Vision Inlay will be implanted in the non-dominant eye.

Detailed Description
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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.

Official Title
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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

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Raindrop Near Vision Inlay


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Study<br>Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects | Device: Raindrop Near Vision Inlay<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision | 75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better | 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preservation of Best Corrected Visual Acuity | 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 | at 6 months postoperatively and all subsequent time points up to 24 months | 
| Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D | Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D | At 6 months postoperatively and all subsequent time points up to 24 months | 
| Occurrence of Adverse Events | Any specific adverse event should occur in less than or equal to 5% of eyes. | During the length of the study, up to 24 months | 
| Uncorrected Intermediate Visual Acuity | 75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better | at 12 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Presbyopia