A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients

NCT02374671 | Completed Results DMC

• 1 other identifier: VIS-2014
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro Insert System for the improvement of near visual acuity in presbyopic patients.

Conditions

Presbyopia

Keywords

Near Vision; Reading Vision; Reading Glasses; Reading; Readers; Presbyopic; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters.

  Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better and Gain of At Least 10 Letters at 24 months for the primary eye.

  From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.

Secondary Outcomes (1)

• Number of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy

  From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.

Study Arms (3)

Implantation-Non-Randomized

EXPERIMENTAL

Subjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria.

Device: VisAbility Micro Insert

Implantation-Randomized

EXPERIMENTAL

Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. VisAbility micro inserts surgically implanted in the eyes. Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.

Device: VisAbility Micro Insert

Deferred Implantation-Randomized

NO INTERVENTION

Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have VisAbility micro inserts surgically implanted in the eye(s) and become part of the overall study experimental group.

Interventions

VisAbility Micro Insert DEVICE

Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.

Implantation-Non-Randomized; Implantation-Randomized

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have a Best Corrected Distance Visual Acuity (BCDVA) of 20/20 in each eye
• Subjects must have a Distance Corrected Near Visual Acuity (DCNVA) @ 40 cm of 20/50, 20/63, or 20/80 in each eye
• Subjects must have an Uncorrected Near Visual Acuity (UCNVA) @ 40 cm of 20/50, 20/63, or 20/80 in each eye
• Subject's Preoperative Manifest Refraction Spherical Equivalent (MRSE) in each eye must be -0.75 to +0.50 diopters with no more than 1.00 diopter of astigmatism.
• Cycloplegic refraction spherical equivalent (CRSE) difference from MRSE should be less than or equal to 0.50 diopters.
• Subjects must require a minimum add of +1.25 or greater to read 20/20 at near (40 cm).
• Subjects must be alert, mentally competent, and able to understand and comply with the requirements of the clinical study, and be personally motivated to abide by the requirements and restrictions of the clinical study. Patients must be available for the follow-up period.
• Subjects must be able to provide written informed consent

You may not qualify if:

• Pupil has a baseline percent change from scotopic to photopic of less than 30% or an absolute difference of less than 1.00 mm between scotopic and photopic pupil size as measured by the NeurOptics Pupillometer
• Subjects with ocular inflammation, chronic uveitis, or other recurrent anterior or posterior segment inflammatory conditions in either eye; subjects with any ocular or systemic disease(s) posing a significant risk for ocular inflammation including but not limited to, autoimmune disorders (e.g. rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, ulcerative colitis, Chron's disease, psoriasis, sarcoidosis, Bechet's disease), infections (toxoplasmosis, cat-scratch fever, West Nile virus, syphilis, tuberculosis, herpes zoster, herpes simplex, adenovirus), ocular trauma or gout.
• Subjects with scleral thickness of less than 530 microns as measured 3.5 to 40.00 mm posterior to the superior temporal quadrant limbus in either eye.
• Subjects with a history of any prior intraocular procedure (e.g. corneal transplant, filtering procedures for glaucoma, vitrectomy, retinal detachment repair, cataract surgery) or any prior refractive procedure (e.g. LASIK (laser in situ keratomileusis), surface excimer, or incisional surgery) in either eye.
• Subjects with any history of prior extraocular muscle surgery or orbital surgery.
• Subjects with chronic ocular disease including but not limited to corneal pathology, primary or secondary glaucoma, iritis, herpes simplex, uveitis, trachoma, ocular pemphigoid, Sjogrens disease, uveal melanoma, Thyroid Related Immune Orbitopathy or clinical significant retinal pathology in either eye.
• Subjects with any acute ocular disease that has not been completely treated and resolved for at least three months such as conjunctivitis, blepharitis, chalazion, corneal abrasion or keratitis in either eye.
• Subjects with chronic systemic diseases which may affect the eye, including but not limited to diabetes, ulcerative colitis, systemic lupus erythematosus, Chron's disease, collagen vascular disease, rheumatoid arthritis, any bleeding diathesis, or systemic manifestations of HIV/AIDS. Any other uncontrolled systemic disease (e.g. hypertension, cancer, etc.) that could compromise the patient's participation.
• Use of any medication such as Coumadin, that could make the surgical procedure more difficult. Subjects using Coumadin, aspirin, or NSAID (non-steroidal anti inflammatory drug) medications under orders from a doctor must be able to provide written approval from the treating doctor for discontinuing this medication at least 10 days prior to surgery.
• Subjects with chronic ocular surface disease, including but not limited to subjects with a prior diagnosis of chronic dry eye syndrome based on tests such as but not limited to, corneal or conjunctival staining, Ocular surface Disease Index symptom score or Schirmer tear testing.
• Subjects who are allergic to any medications used in the protocol
• Subjects who are pregnant, lactating, or of child-bearing age adn not practicing a medically approved method of birth control.

Sponsors & Collaborators

• Refocus Group, Inc.: lead

Study Sites (14)

Coastal Vision

Orange, California, 92868, United States

Location

Gordon Weiss Vision Institute

San Diego, California, 92122, United States

Location

Aloha Laser Vision

Honolulu, Hawaii, 96814, United States

Location

The Midwest Center for Sight

Des Plaines, Illinois, 60016, United States

Location

Eye Surgeons Of Indiana PC

Indianapolis, Indiana, 46256, United States

Location

Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

South Shore Eye Care LLP

Wantagh, New York, 11793, United States

Location

South Shore Eye Care, LLP

Wantagh, New York, 11793, United States

Location

Physicians Protocol

Greensboro, North Carolina, 27401, United States

Location

Comprehensive EyeCare of Central Ohio

Westerville, Ohio, 43082, United States

Location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Key Whitman Eye Center

Dallas, Texas, 75242, United States

Location

Braverman-Terry-Oei Eye Associates

San Antonio, Texas, 78212, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Presbyopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Regulatory & Quality
• Organization: Refocus Group, Inc.

lstewart@refocus-group.com

214-368-0200

Study Officials

• Selene Burke, O.D.

  V.P. Clinical Affairs

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Model Details: A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 2, 2015
• Study Start: November 15, 2014
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)