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PresbyopiaNCT01373580

A Clinical Trial to Evaluate a Corneal Inlay for the Improvement of Near Vision in Presbyopic Patients

A study testing The Raindrop Near Vision Inlay in people with Presbyopia, run by ReVision Optics, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Presbyopia
What is being tested?
The Raindrop Near Vision Inlay
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
373 participants
Where
11 sitesUnited States
Study dates
Apr 2010to 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 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • must be presbyopic adults, needing from +1.50 to +2.50 or reading add must have uncorrected near visual acuity worse than 20/40 and better than 20/200in the eye to be implanted must have an uncorrected distance visual acuity of 20/25 or better in both eyes must have a distance visual acuity correctable to 20/20 in both eyes must have a near visual acuity correctable to 20/20 in both eyes must have a manifest refraction spherical equivalent between -0.50 and +1.00D in the eye to be implanted with no more than 0.75D of refractive cylinder must report stable vision, i.e. no change in distance vision and or MRSE within 0.50D over prior 12 months 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 must have a minimum central corneal thickness of >500 microns in the eye to be implanted must have a mesopic pupil < 7.0mm and photopic pupil >3.0mm in the eye to be implanted subjects aged 45 years or younger must have an endothelial cell count

Who cannot join

  • Subjects with a difference of >0.75 between the manifest refraction spherical equivalent and the cycloplegic refraction spherical equivalent Subjects with anterior segment pathology, including clinically significant cataracts, in the non-dominant eye Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the non-dominant eye Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the non-dominant eye Subjects with clinically significant dry eyes, as determined by either the presence of greater than mild symptoms of dryness or discomfort or SPK greater than grade 1 Subjects with distorted or unclear mires on topography maps of the non-dominant eye Subjects with macular degeneration, retinal detachment, or any other fundus pathology that would prevent an acceptable visual outcome in the non-dominant eye Subjects who have undergone LASIK surgery in the non-dominant eye Subjects with a history of herpes zoster or herpes simplex keratitis Subjects who have a history of steroid responsive rise in intraocular pressure, pre-operative IOP>21 mm Hg, glaucoma or are a glaucoma suspect Subjects with a history of diagnosed 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 mediation(s) other than artificial tears for treatment of any ocular pathology Subjects using systemic medications with significant ocular side effects Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study Subjects what are participating in any other ophthalmic drug or device studies during the time of this clinical investigation Subjects with known sensitivity to planned study concomitant medications
  • -

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Chu Vision

    Bloomington, Minnesota, 55420

  • Dougherty Laser Vision

    Camarillo, California, 93010

  • Key-Whitman Eye Center

    Dallas, Texas, 75204

  • Carter Eye Center

    Dallas, Texas, 75205

  • Jon G. Dishler, M.D.

    Greenwood Village, Colorado, 80111

  • Eyesight Hawaai

    Honolulu, Hawaii, 96816

  • Slade and Baker Vision Center

    Houston, Texas, 77027

  • Harvard Eye Associates

    Laguna Hills, California, 92653

  • Lehmann Eye Center

    Nacogdoches, Texas, 75965

  • Coastal Vision

    Newport Beach, California, 92660

  • NuVision.

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Prospective, Multinational Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ReVision Optics, Inc. PresbyLens Corneal Inlay for the Improvement of Near Vision in Presbyopic Subjects With MRSE From -0.50 to +1.00

This study will be a prospective, multicenter clinical trial in which a total of 400 subjects will be enrolled. All subjects will be followed over a 36 month time frame with a maximum of 15 clinical sites participating. Qualified subjects will provide informed consent for entry into the study.

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. Loss of accommodation begins early in life and, for an emmetropic eye, generally culminates in a complete loss of functional near vision.

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 (LASIK)has been made. The Raindrop is expected to provide presbyopic subjects with improvement of near and intermediate vision.

Conditions
Presbyopia
Being tested
The Raindrop Near Vision Inlay
Keywords
presbyopia, LASIK, loss of accommodation, Emmetrope
Medical subject headings
Presbyopia

What participants receive

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

  • The Raindrop Near Vision InlayDevice

    Also called Presbylens

    The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia

Study groups in NCT01373580
Study groupRoleWhat they receive
RaindropExperimentalA 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 vision.
Receives: Device: The Raindrop Near Vision Inlay

What is being measured

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

  1. Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye

    75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline

    Measured: 24 Months

Secondary outcomes (2)

  1. Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye

    Less than 5% of participants should lose more than two lines of best corrected distance and near visual acuity in the implanted eye; and less than 1% of participants with preoperative best spectacle corrected visual acuity (BCDVA) of 20/20 in the implanted eye should have best corrected distance and near visual acuity worse than 20/40 in the implanted eye at 6 months postoperative and all subsequent visits.

    Measured: at 6 months postoperative and all subsequent visits

  2. Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye

    Less than 5% of participants should have postoperative manifest refractive astigmatism in the implanted eye that increases from baseline by greater than 2.00 D at 6 months postoperative and all subsequent visits.

    Measured: At 6 months postoperative and all subsequent visits

Timeline

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

  1. First posted15 Jun 2011 (estimated)
  2. Study startApr 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01373580
Sponsor's protocol ID
P09-0003
Status last verified
Mar 2018
First submitted
13 Jun 2011
Last updated
29 Mar 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Whitman J, Dougherty PJ, Parkhurst GD, Olkowski J, Slade SG, Hovanesian J, Chu R, Dishler J, Tran DB, Lehmann R, Carter H, Steinert RF, Koch DD. Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes. Ophthalmology. 2016 Mar;123(3):466-75. doi: 10.1016/j.ophtha.2015.11.011. Epub 2016 Jan 27.

    PubMed 26804761

Questions about this trial

What is this clinical trial studying?

A study testing The Raindrop Near Vision Inlay in people with Presbyopia, run by ReVision Optics, Inc. at 11 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 29 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 11 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 29 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?

Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye (time frame: 24 Months). 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 NCT01373580, which also lists 1 linked publication.

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 29 Mar 2018.

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