AzTrials
AzTrials

PresbyopiaPhase 3NCT02668523

A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near and Intermediate Vision in Pseudophakic Presbyopic Subjects

A Phase 3 study testing Raindrop Near Vision Inlay in people with Presbyopia and Pseudophakia, run by ReVision Optics, Inc. at 13 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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?
Ages 50 years and older
Conditions the study is for
Presbyopia, Pseudophakia
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
400 participants
Where
13 sitesUnited States
Study dates
Dec 2015to Jul 2018
Phase
Phase 3
Are there results?
None posted in the registry

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 50 years and older
  • All sexes
  • No healthy volunteers
  • 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 be at least 50 years old
  • Subjects must have uncorrected near visual acuity worse than 20/40 and better than 20/200 in the non-dominant eye.
  • Subjects must have monocular 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.
Show all 19Show fewer
  • 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 480 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 endothelial cell count ≥ 2200 cells/mm2 in the eye to be implanted (non-dominant).
  • Subjects who are contact lens wearers must discontinue hard or rigid gas permeable lenses for at least 3 weeks and discontinue soft lenses for at least 1 week prior to baseline examination.
  • Subjects who are contact lens wearers must have two (2) central keratometry readings with regular mires and two (2) manifest refractions taken at least one week apart, with no contact lens wear between. Keratometric values must not differ by more than ± 0.50 D in any meridian the eye to be implanted. MRSE values must not differ more than ±0.50 D in the non-dominant eye.
  • Subjects must have documented monovision tolerance as determined by a 5-day contact lens trial prior to surgery.
  • 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 visual examinations after IOL implantation, performed at least 3 months apart.
  • Subjects must have a clear or open posterior capsule in the non-dominant eye.
  • Subjects must be willing and able to return for scheduled follow-up examinations for 24 months after surgery.

Who cannot join

  • Subjects with anterior chamber or multifocal IOLs (intraocular lens) in either eye.
  • Subjects with clinically significant anterior segment pathology in either eye.
  • Subjects who have worn soft or rigid contact lenses within the past 30 days in the eye to be treated (excludes the contact lens trial for monovision tolerance).
  • 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.
  • Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in either eye.
  • Subjects with distorted or unclear corneal mires on topography maps of the non- dominant eye.
Show all 19Show fewer
  • Subjects who require canthotomy to generate a corneal flap in the non-dominant eye.
  • Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in either eye.
  • Subjects who have undergone previous corneal surgery including LASIK surgery in the non-dominant eye.
  • Subjects with a history of ocular herpes zoster or ocular herpes simplex keratitis.
  • Subjects who have a history of steroid-responsive rise in intraocular pressure, preoperative IOP > 21 mm Hg, glaucoma, or who are a glaucoma suspect in either eye.
  • Subjects with a history of uncontrolled diabetes, autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
  • Subjects on chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised subjects.
  • Subjects who are using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology excluding ocular allergy.
  • Subjects using systemic medications with significant ocular side effects.
  • Subjects with known sensitivity to planned study concomitant medications.
  • Subjects who are participating in any other clinical trial during the course of this clinical investigation.
  • Subjects who have had previous astigmatic keratotomy or limbal relaxing incisions at the time of cataract surgery.
  • Subjects who are of child bearing potential and who have a positive pregnancy test result, prior to surgery.

Trial locations and contacts

13 sites in 1 country.

Lynne Archer contact

949-707-2740 ext. 239

larcher@revisionoptics.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • Chu Vision Institute

    Bloomington, Minnesota, 55420

    Nic Jacobs, 952-835-1235, Nic.Jacobs@chuvision.com

    Miranda Grebowski, 952-835-1235, Miranda.Grebowski@chuvision.com

    Recruiting

  • The Bowie Vision Institute

    Bowie, Maryland, 20716

    Tasia Mitchell, 301-464-1885, tmitchell@solomoneye.net

    Jonathan Solomon, MD

    Recruiting

  • The Eye Associates of Manatee

    Bradenton, Florida, 34209

    Rebecca Stidham, 941-792-3937, rstidham@theeyeassociates.com

    Cathleen McCabe, MD

    Recruiting

  • Cleveland Eye Clinic

    Brecksville, Ohio, 44141

    Chelsea Amstutz, 440-526-1974 ext. 354, camstutz@clevelandeyeclinic.com

    William F Wiley, MD

    Recruiting

  • Key-Whitman Eye Center

    Dallas, Texas, 75243

    Jason Chan, 214-754-0000, jason.chan@keywhitman.com

    Jeffrey Whitman, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Amanda Vega, 713-798-6100, amandav@bcm.edu

    Douglas D Koch, MD

    Recruiting

  • Harvard Eye Associates

    Laguna Hills, California, 92653

    Natalie Edwards, 949-842-9954, nedwards@harvardeye.com

    John A Hovanesian, MD

    Recruiting

  • The Eye Institute of West Florida

    Largo, Florida, 33770

    Renee Bondurant, 727-450-4668, renee.bondurant@eyespecialist.com

    Robert Weinstock, MD

    Recruiting

  • Coastal Vision Laser Eye Center

    Orange, California, 92868

    Natalie Edwards, 949-842-9954, natalieedwardsresearch@gmail.com

    Dan B Tran, MD

    Recruiting

  • The Eye Institute of Utah

    Salt Lake City, Utah, 84107

    Jamie Slade, 801-263-5753, jslade@theeyeinstitute.com

    Natalie Forcht, 801-263-5753, nforcht@theeyeinstitute.com

    Recruiting

  • Parkhurst NuVision

    San Antonio, Texas, 78229

    Maria Saenz, 210-428-6788, msaenz@SanAntonio-Lasik.com

    Gregory D Parkhurst, MD

    Recruiting

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

    Samantha Nielson, 605-371-7074, samantha.nielson@vancethompsonvision.com

    Keeley Puls, 605-371-7074, keeley.puls@vancethompsonvision.com

    Recruiting

  • Associated Eye Care

    Stillwater, Minnesota, 55082

    Patricia Johnson, 651-275-3000, pjohnson@associatedeyecare.com

    Stephen S Lane, MD

    Recruiting

Other trials in United States

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.

Read the detailed description

The loss of near vision and the ability to perform tasks that require near vision is part of the normal aging process. This natural transformation in the eye occurs as a result of the loss of accommodation of the crystalline lens, a condition known as presbyopia. Presbyopia, characterized by a progressive, age-related loss of accommodation (i.e., the lens ability to focus clearly over a wide range of distances), is most prevalent of all visual deficiencies, affecting 100% of the population over the course of a normal life span.

Presbyopia is also 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 present limitations from the patient perspective.

ReVision Optics has developed the Raindrop corneal inlay for the correction of near vision. The Raindrop is a 2mm corneal inlay, as small as a pinhead, thinner than a human hair and about 1/500th of a droplet of water. 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 or corneal pocket has been made. The Raindrop is expected to provide pseudophakic presbyopic subjects with improvement of near and intermediate vision.

Being tested
Raindrop Near Vision Inlay
Keywords
Presbyopia, Corneal Inlay, Pseudophakic, Pseudophakia
Medical subject headings
Presbyopia, Pseudophakia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Raindrop Near Vision InlayDevice

    To improve the near and intermediate vision in subjects who have previously undergone cataract surgery (pseudophakic subjects)

Study groups in NCT02668523
Study groupRoleWhat they receive
RaindropExperimentalA single arm study to evaluate the effectiveness of a 2mm Raindrop Near Vision Inlay for the treatment of presbyopia in pseudophakic subjects. This corneal inlay is placed under a LASIK flap or in a corneal pocket, and is designed to change the anterior curvature of the cornea, resulting in the ability to reduce spectacle dependency for near and intermediate tasks.
Receives: Device: Raindrop Near Vision Inlay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in uncorrected near visual acuity

    Seventy-five percent of eyes should achieve uncorrected near visual acuity of 20/40 or better.

    Measured: 24 Months

  2. Preservation of best corrected visual acuity

    Fewer than five percent of eyes should lose more than 2 lines of best corrected distance visual acuity after implantation

    Measured: 24 Months

Secondary outcomes (2)

  1. Improvement in uncorrected intermediate visual acuity

    Seventy-five percent of eyes should achieve uncorrected intermediate visual acuity of 20/40 or better (measured at 80cm/32 inches)

    Measured: 24 Months

  2. Adverse Events

    Adverse events should occur in less than 10% of eyes and any single adverse event should occur in less than 2.5% of eyes.

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionMar 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668523
Sponsor's protocol ID
P15-0010
Status last verified
Jan 2017
First submitted
26 Jan 2016
Last updated
10 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Raindrop Near Vision Inlay in people with Presbyopia and Pseudophakia, run by ReVision Optics, Inc. at 13 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 19 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lynne Archer (949-707-2740 ext. 239, larcher@revisionoptics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in uncorrected near visual acuity (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668523.

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 10 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in