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

NCT02668523 | Unknown Phase 3

• 1 other identifier: P15-0010
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Presbyopia; Pseudophakia

Keywords

Presbyopia; Corneal Inlay; Pseudophakic; Pseudophakia

Outcome Measures

Primary Outcomes (2)

• Improvement in uncorrected near visual acuity

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

  24 Months

• 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

  24 Months

Secondary Outcomes (2)

• Improvement in uncorrected intermediate visual acuity

  24 Months

• Adverse Events

  24 Months

Study Arms (1)

Raindrop

EXPERIMENTAL

A 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.

Device: Raindrop Near Vision Inlay

Interventions

Raindrop Near Vision Inlay DEVICE

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

Raindrop

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• ReVision Optics, Inc.: lead

Study Sites (13)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

RECRUITING

Coastal Vision Laser Eye Center

Orange, California, 92868, United States

RECRUITING

The Eye Associates of Manatee

Bradenton, Florida, 34209, United States

RECRUITING

The Eye Institute of West Florida

Largo, Florida, 33770, United States

RECRUITING

The Bowie Vision Institute

Bowie, Maryland, 20716, United States

RECRUITING

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

RECRUITING

Associated Eye Care

Stillwater, Minnesota, 55082, United States

RECRUITING

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

RECRUITING

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Parkhurst NuVision

San Antonio, Texas, 78229, United States

RECRUITING

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia; Pseudophakia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lynne Archer

CONTACT

949-707-2740; larcher@revisionoptics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 10, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)