A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Study Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects |
Device: Raindrop Near Vision Inlay
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision [12 months postoperatively]
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 [at 6 months postoperatively and all subsequent time points up to 24 months]
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 [At 6 months postoperatively and all subsequent time points up to 24 months]
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 [During the length of the study, up to 24 months]
Any specific adverse event should occur in less than or equal to 5% of eyes.
- Uncorrected Intermediate Visual Acuity [at 12 months postoperatively]
75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
Eligibility Criteria
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.
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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.
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Subjects must have a central corneal thickness of between 500 and 600 microns in the non-dominant eye.
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Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.
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Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.
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Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the non-dominant eye.
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Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.
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Subjects must have documented monovision tolerance.
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Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.
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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.
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Subjects must have a clear or open posterior capsule in the non-dominant eye. -
Exclusion Criteria:
-
- Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or multifocal intraocular lenses (IOLs) in either eye.
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Subjects with anterior segment pathology in either eye.
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Subjects who have worn soft or rigid contact lenses within the past 30 days in the eye to be treated.
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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.
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Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in either eye.
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Subjects with distorted or unclear corneal mires on topography maps of the non- dominant eye.
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Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.
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Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in either eye.
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Subjects who have undergone previous corneal surgery including LASIK surgery in the non-dominant eye.
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Subjects with a history of herpes zoster or herpes simplex keratitis.
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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.
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Subjects with a history of uncontrolled diabetes, autoimmune disease connective tissue disease, or clinically significant atopic syndrome.
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Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
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Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology excluding ocular allergy.
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Subjects using systemic medications with significant ocular side effects.
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Subjects with known sensitivity to planned study concomitant medications.
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Subjects who are participating in any other clinical trial during the course of this clinical investigation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Harvard Eye Associates | Laguna Hills | California | United States | 92653 |
| 2 | Coastal Vision | Orange | California | United States | 92868 |
| 3 | Chu Vision Institute | Bloomington | Minnesota | United States | 55420 |
| 4 | Key-Whitman Eye Center | Dallas | Texas | United States | 75204 |
| 5 | Carter Eye Center | Dallas | Texas | United States | 75205 |
| 6 | Parkhurst-NuVision | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- ReVision Optics, Inc.
Investigators
- Study Chair: Roger Steinert, MD, Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P13-0064
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Period Title: Overall Study | |
| STARTED | 13 |
| COMPLETED | 11 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Overall Participants | 13 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
5
38.5%
|
| >=65 years |
8
61.5%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
53.8%
|
| Male |
6
46.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Caucasian |
10
76.9%
|
| African American |
1
7.7%
|
| Asian |
0
0%
|
| Hispanic |
2
15.4%
|
| Other |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
13
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Measure Participants | 13 |
| Number [Percentage of Implanted Eyes] |
100
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Measure Participants | 12 |
| Number [Percentage of Implanted Eyes] |
92
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Measure Participants | 13 |
| Number [Percentage of Implanted Eyes] |
0
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Measure Participants | 13 |
| Intraocular Pressure increase |
2
|
| Inlay Explant |
2
|
| Diffuse Lamellar Keratitis |
1
|
| Loss of BCVA due to late onset of haze |
1
|
| Hospitalization |
1
|
| Epiretinal Membrane |
1
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Study |
|---|---|
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. |
| Measure Participants | 12 |
| Number [Percentage of Implanted Eyes] |
92
|
Adverse Events
| Time Frame | 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Single Arm Study | |
| Arm/Group Description | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: 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. | |
All Cause Mortality |
||
| Single Arm Study | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Single Arm Study | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/13 (7.7%) | |
| Musculoskeletal and connective tissue disorders | ||
| Hospitalization due to triple arthrodesis surgery (secondary to muscular dystrophy) | 1/13 (7.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Single Arm Study | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/13 (38.5%) | |
| Eye disorders | ||
| Increase in intraocular pressure > 10mmHg above baseline | 2/13 (15.4%) | 2 |
| Inlay explant | 2/13 (15.4%) | 2 |
| Diffuse Lamellar Keratitis (DLK) | 1/13 (7.7%) | 1 |
| Loss of BCVA due to late onset of haze | 1/13 (7.7%) | 1 |
| Epiretinal Membrane | 1/13 (7.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The investigator agreed to hold this information in confidence and not to disclose it to any third parties for a period of three years from the date of this agreement, or until this information becomes a matter of public knowledge or until a formal agreement for that purpose has been entered into by the parties.
Results Point of Contact
| Name/Title | Tracy Shwaery, Global Clinical Research Manager |
|---|---|
| Organization | Ms. |
| Phone | 9497072740 ext 157 |
| tshwaery@revisionoptics.com |
- P13-0064