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

Status unconfirmed · Phase 3

Conditions studied: Presbyopia, Pseudophakia

In brief

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.

Key facts

Study ID

NCT02668523

Run by

ReVision Optics, Inc.

People needed

400

Starts

2015-12-01

Expected to finish

2018-07-01

Last updated by the study team

2017-01-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Harvard Eye Associates — Laguna Hills, California, United States (enrolling)
• Coastal Vision Laser Eye Center — Orange, California, United States (enrolling)
• The Eye Associates of Manatee — Bradenton, Florida, United States (enrolling)
• The Eye Institute of West Florida — Largo, Florida, United States (enrolling)
• The Bowie Vision Institute — Bowie, Maryland, United States (enrolling)
• Chu Vision Institute — Bloomington, Minnesota, United States (enrolling)
• Associated Eye Care — Stillwater, Minnesota, United States (enrolling)
• Cleveland Eye Clinic — Brecksville, Ohio, United States (enrolling)
• Vance Thompson Vision — Sioux Falls, South Dakota, United States (enrolling)
• Key-Whitman Eye Center — Dallas, Texas, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• Parkhurst NuVision — San Antonio, Texas, United States (enrolling)
• The Eye Institute of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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