ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 212 for:    Louisville AND placement

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02374671
Recruitment Status : Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Refocus Group, Inc.

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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: VisAbility Micro Insert Not Applicable

Detailed Description:

The objective of this study is to evaluate the safety and effectiveness of the VisAbility Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This is a prospective clinical study that will enroll and determine eligible a total of 360 subjects ranging in age between 45 and 60 years of age at up to 14 clinical sites. Subjects will be implanted with the VisAbility Implant model SGP-046 in the primary eye and then in the fellow eye no sooner than 14 days later. Subjects will be examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.

The study will also include a 60 subject randomized controlled sub-study at 3 investigational sites. Subjects enrolled and eligible at these sites will be randomized (1:1 ratio) to a surgery group or a control group. Subjects randomized to the surgery group will undergo surgery and will be followed for 24 months in the same manner as the larger non-randomized surgical group. Subjects randomized to the control group will be followed for 6 months, and will be eligible to undergo surgery after completion of this 6-month follow-up period.

The primary endpoint is achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.

This endpoint will be evaluated against two objectives, a) 75% or more of primary eyes achieve the effectiveness endpoint at 12 months postoperative and b) the percentage of primary eyes achieving the effectiveness endpoint at 6 months postoperative (6-month responder rate) is higher than the percentage in the randomized control group.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Clinical Trial Of The VisAbility Micro Insert System For Improvement Of Near Visual Acuity In Presbyopic Patients
Study Start Date : November 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: Treatment via Procedure/Surgery
The VisAbility Micro Insert treatment is for the improvement of near visual acuity in presbyopic patients. Subjects will receive the VisAbility Micro Inserts via a Procedure/Surgery.
Device: VisAbility Micro Insert
The VisAbility Micro Insert (Model SGP-046) is an injection molded curved scleral implant molded from PMMA (polymethylmethacrylate), a material with an extensive history of long-term implantation in the human eye, including intraocular lenses (IOLs). Four (4) VisAbility Micro Insert segments are placed in a single presbyopic eye to improve near vision.




Primary Outcome Measures :
  1. Distance Corrected Near Visual Acuity [ Time Frame: From date of randomization until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years ]
    Achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374671


Locations
United States, California
Coastal Vision
Orange, California, United States, 92868
Gordon Weiss Vision Institute
San Diego, California, United States, 92122
United States, Hawaii
Aloha Laser Vision
Honolulu, Hawaii, United States, 96814
United States, Illinois
The Midwest Center for Sight
Des Plaines, Illinois, United States, 60016
United States, Indiana
Eye Surgeons Of Indiana PC
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Eye Care Institute
Louisville, Kentucky, United States, 40206
United States, Minnesota
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
United States, New York
South Shore Eye Care LLP
Wantagh, New York, United States, 11793
United States, North Carolina
Physicians Protocol
Greensboro, North Carolina, United States, 27401
United States, Ohio
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, United States, 43082
United States, Pennsylvania
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, United States, 18702
United States, Texas
Key Whitman Eye Center
Dallas, Texas, United States, 75242
Braverman-Terry-Oei Eye Associates
San Antonio, Texas, United States, 78212
Sponsors and Collaborators
Refocus Group, Inc.
Investigators
Principal Investigator: David Schanzlin, M.D. Chief Medical Officer

Additional Information:
Responsible Party: Refocus Group, Inc.
ClinicalTrials.gov Identifier: NCT02374671     History of Changes
Other Study ID Numbers: VIS-2014
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Refocus Group, Inc.:
Near Vision
Reading Vision
Reading Glasses
Reading
Readers
Presbyopic

Additional relevant MeSH terms:
Presbyopia
Refractive Errors
Eye Diseases