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

Stopped early · Not applicable

Conditions studied: Presbyopia

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. 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.

Key facts

Study ID

NCT03017612

Run by

ReVision Optics, Inc.

People needed

13

Starts

2014-07-01

Expected to finish

2016-12-01

Last updated by the study team

2018-03-01

Who can join

Age: any. 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 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.
• 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. -

You may not qualify if…

• 1. Subjects with anterior chamber IOLs, or posterior chamber, accommodating, or multifocal intraocular lenses (IOLs) in either eye.
• Subjects with 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.
• 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 herpes zoster or herpes simplex keratitis.
• 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.
• 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.

Where it is running

• Harvard Eye Associates — Laguna Hills, California, United States
• Coastal Vision — Orange, California, United States
• Chu Vision Institute — Bloomington, Minnesota, United States
• Key-Whitman Eye Center — Dallas, Texas, United States
• Carter Eye Center — Dallas, Texas, United States
• Parkhurst-NuVision — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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