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

Completed · Not applicable

Conditions studied: Presbyopia

In brief

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.

Key facts

Study ID

NCT02374671

Run by

Refocus Group, Inc.

People needed

365

Starts

2014-11-15

Expected to finish

2018-04-13

Last updated by the study team

2020-01-06

Who can join

Age: 45 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Coastal Vision — Orange, California, United States
• Gordon Weiss Vision Institute — San Diego, California, United States
• Aloha Laser Vision — Honolulu, Hawaii, United States
• The Midwest Center for Sight — Des Plaines, Illinois, United States
• Eye Surgeons Of Indiana PC — Indianapolis, Indiana, United States
• Eye Care Institute — Louisville, Kentucky, United States
• Chu Vision Institute — Bloomington, Minnesota, United States
• South Shore Eye Care LLP — Wantagh, New York, United States
• South Shore Eye Care, LLP — Wantagh, New York, United States
• Physicians Protocol — Greensboro, North Carolina, United States
• Comprehensive EyeCare of Central Ohio — Westerville, Ohio, United States
• Bucci Laser Vision — Wilkes-Barre, Pennsylvania, United States
• Key Whitman Eye Center — Dallas, Texas, United States
• Braverman-Terry-Oei Eye Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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