PresbyopiaNCT03017612
A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects
A study testing Raindrop Near Vision Inlay in people with Presbyopia, run by ReVision Optics, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Presbyopia
- What is being tested?
- Raindrop Near Vision Inlay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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. -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Chu Vision Institute
Bloomington, Minnesota, 55420
Key-Whitman Eye Center
Dallas, Texas, 75204
Carter Eye Center
Dallas, Texas, 75205
Harvard Eye Associates
Laguna Hills, California, 92653
Coastal Vision
Orange, California, 92868
Parkhurst-NuVision
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- Raindrop Near Vision Inlay
- Keywords
- Presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raindrop Near Vision InlayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Receives: Device: Raindrop Near Vision Inlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months postoperatively
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: at 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Change of inlay from no bevel to bevel design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReVision Optics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Steinert, MD, Study chair, Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017612
- Sponsor's protocol ID
- P13-0064
- Status last verified
- Feb 2018
- First submitted
- 12 Feb 2015
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03017612
- Acronym / sponsor ID
- P13-0064
- Conditions
- Presbyopia
- Keywords
- Presbyopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of inlay from no bevel to bevel design
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ReVision Optics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Device: Raindrop Near Vision InlayEvaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raindrop Near Vision InlayA 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. | Device | Single Arm Study |
Primary outcome
Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision
Time frame: 12 months postoperatively
75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better
4 secondary outcomes
Preservation of Best Corrected Visual Acuity
Time frame: 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
Time frame: At 6 months postoperatively and all subsequent time points up to 24 months
Occurrence of Adverse Events
Time frame: During the length of the study, up to 24 months
Uncorrected Intermediate Visual Acuity
Time frame: at 12 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Steinert, MD study chair
Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raindrop Near Vision Inlay in people with Presbyopia, run by ReVision Optics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.