Back to resultsA Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
Primary Purpose
Presbyopia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raindrop Near Vision Inlay
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia focused on measuring Presbyopia
Eligibility Criteria
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.
Sites / Locations
- Harvard Eye Associates
- Coastal Vision
- Chu Vision Institute
- Key-Whitman Eye Center
- Carter Eye Center
- Parkhurst-NuVision
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm Study
Arm Description
Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Occurrence of Adverse Events
Any specific adverse event should occur in less than or equal to 5% of eyes.
Uncorrected Intermediate Visual Acuity
75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
Full Information
NCT ID
NCT03017612
First Posted
February 12, 2015
Last Updated
February 1, 2018
Sponsor
ReVision Optics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03017612
Brief Title
A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Change of inlay from no bevel to bevel design
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReVision Optics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia
Keywords
Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm Study
Arm Type
Experimental
Arm Description
Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects
Intervention Type
Device
Intervention Name(s)
Raindrop Near Vision Inlay
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision
Description
75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better
Time Frame
12 months postoperatively
Secondary Outcome Measure Information:
Title
Preservation of Best Corrected Visual Acuity
Description
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
Time Frame
at 6 months postoperatively and all subsequent time points up to 24 months
Title
Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D
Description
Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D
Time Frame
At 6 months postoperatively and all subsequent time points up to 24 months
Title
Occurrence of Adverse Events
Description
Any specific adverse event should occur in less than or equal to 5% of eyes.
Time Frame
During the length of the study, up to 24 months
Title
Uncorrected Intermediate Visual Acuity
Description
75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
Time Frame
at 12 months postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Steinert, MD
Organizational Affiliation
Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA
Official's Role
Study Chair
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Coastal Vision
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Carter Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75205
Country
United States
Facility Name
Parkhurst-NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
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