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

NCT03017612 | Terminated Results

• 1 other identifier: P13-0064
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 6

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. 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.

Conditions

Presbyopia

Keywords

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision

  75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better

  12 months postoperatively

Secondary Outcomes (4)

• Preservation of Best Corrected Visual Acuity

  at 6 months postoperatively and all subsequent time points up to 24 months

• Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D

  At 6 months postoperatively and all subsequent time points up to 24 months

• Occurrence of Adverse Events

  During the length of the study, up to 24 months

• Uncorrected Intermediate Visual Acuity

  at 12 months postoperatively

Study Arms (1)

Single Arm Study

EXPERIMENTAL

Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects

Device: Raindrop Near Vision Inlay

Interventions

Raindrop Near Vision Inlay DEVICE

A 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 and intermediate vision.

Single Arm Study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), 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 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• ReVision Optics, Inc.: lead

Study Sites (6)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Coastal Vision

Orange, California, 92868, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75204, United States

Location

Carter Eye Center

Dallas, Texas, 75205, United States

Location

Parkhurst-NuVision

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Tracy Shwaery, Global Clinical Research Manager
• Organization: Ms.

tshwaery@revisionoptics.com

9497072740

Study Officials

• Roger Steinert, MD

  Interim Dean, School of Medicine; Irving H. Leopold Professor of Ophthalmology; University of Californa, Irvine, CA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: January 11, 2017
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 1, 2018
• Results First Posted: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)