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

Sponsor
ReVision Optics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03017612
Collaborator
(none)
13
Enrollment
6
Locations
1
Arm
29
Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: Raindrop Near Vision Inlay
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

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

ArmIntervention/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

  1. 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

  1. 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

  2. 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

  3. 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.

  4. 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

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Subjects must provide informed consent, have signed the written informed consent form, and been given a copy.

  2. Subjects must be bilateral pseudophakic adults with presbyopia, needing reading add from +1.50 D to +2.50 D.

  3. Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.

  4. Subjects must have an uncorrected distance visual acuity of 20/25 or better in both eyes.

  5. Subjects must have distance and near visual acuity correctable to at least 20/20 in both eyes.

  6. 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.

  7. Subjects must have a tear break-up time (TBUT) of ≥8 seconds.

  8. Subjects must have a central corneal thickness of between 500 and 600 microns in the non-dominant eye.

  9. Subjects must have an average corneal power of ≥ 41.00 D and ≤ 47.00 D in the non-dominant eye.

  10. Subjects must have a photopic pupil size of ≥3.0 mm, in the non-dominant eye.

  11. Subjects must have an estimated endothelial cell count of ≥ 2000 cells/mm2 in the non-dominant eye.

  12. Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.

  13. Subjects must have documented monovision tolerance.

  14. Subjects must have a minimum of 3 months between cataract surgery and implantation of the Raindrop Near Vision Inlay in the non-dominant eye.

  15. 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.

  16. 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.
  1. Subjects with anterior segment pathology in either eye.

  2. Subjects who have worn soft or rigid contact lenses within the past 30 days in the eye to be treated.

  3. 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.

  4. Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in either eye.

  5. Subjects with distorted or unclear corneal mires on topography maps of the non- dominant eye.

  6. Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.

  7. Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in either eye.

  8. Subjects who have undergone previous corneal surgery including LASIK surgery in the non-dominant eye.

  9. Subjects with a history of herpes zoster or herpes simplex keratitis.

  10. 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.

  11. Subjects with a history of uncontrolled diabetes, autoimmune disease connective tissue disease, or clinically significant atopic syndrome.

  12. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.

  13. Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology excluding ocular allergy.

  14. Subjects using systemic medications with significant ocular side effects.

  15. Subjects with known sensitivity to planned study concomitant medications.

  16. Subjects who are participating in any other clinical trial during the course of this clinical investigation.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Harvard Eye AssociatesLaguna HillsCaliforniaUnited States92653
2Coastal VisionOrangeCaliforniaUnited States92868
3Chu Vision InstituteBloomingtonMinnesotaUnited States55420
4Key-Whitman Eye CenterDallasTexasUnited States75204
5Carter Eye CenterDallasTexasUnited States75205
6Parkhurst-NuVisionSan AntonioTexasUnited States78229

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.
Responsible Party:
ReVision Optics, Inc.
ClinicalTrials.gov Identifier:
NCT03017612
Other Study ID Numbers:
  • P13-0064
First Posted:
Jan 11, 2017
Last Update Posted:
Mar 1, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by ReVision Optics, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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
STARTED13
COMPLETED11
NOT COMPLETED2

Baseline Characteristics

Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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 Participants13
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

1. Primary Outcome
TitlePercentage of Implanted Eyes With Improvement in Uncorrected Near Vision
Description75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better
Time Frame12 months postoperatively

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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 Participants13
Number [Percentage of Implanted Eyes]
100
2. Secondary Outcome
TitlePreservation of Best Corrected Visual Acuity
DescriptionFewer 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 Frameat 6 months postoperatively and all subsequent time points up to 24 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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 Participants12
Number [Percentage of Implanted Eyes]
92
3. Secondary Outcome
TitlePercentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D
DescriptionFewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D
Time FrameAt 6 months postoperatively and all subsequent time points up to 24 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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 Participants13
Number [Percentage of Implanted Eyes]
0
4. Secondary Outcome
TitleOccurrence of Adverse Events
DescriptionAny specific adverse event should occur in less than or equal to 5% of eyes.
Time FrameDuring the length of the study, up to 24 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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 Participants13
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
5. Secondary Outcome
TitleUncorrected Intermediate Visual Acuity
Description75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better
Time Frameat 12 months postoperatively

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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 Participants12
Number [Percentage of Implanted Eyes]
92

Adverse Events

Time Frame1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months
Adverse Event Reporting Description
Arm/Group TitleSingle Arm Study
Arm/Group DescriptionEvaluating 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
Total1/13 (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
Total5/13 (38.5%)
Eye disorders
Increase in intraocular pressure > 10mmHg above baseline2/13 (15.4%) 2
Inlay explant2/13 (15.4%) 2
Diffuse Lamellar Keratitis (DLK)1/13 (7.7%) 1
Loss of BCVA due to late onset of haze1/13 (7.7%) 1
Epiretinal Membrane1/13 (7.7%) 1

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed.

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/TitleTracy Shwaery, Global Clinical Research Manager
OrganizationMs.
Phone9497072740 ext 157
Emailtshwaery@revisionoptics.com
Responsible Party:
ReVision Optics, Inc.
ClinicalTrials.gov Identifier:
NCT03017612
Other Study ID Numbers:
  • P13-0064
First Posted:
Jan 11, 2017
Last Update Posted:
Mar 1, 2018
Last Verified:
Feb 1, 2018