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

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 enrolled a total of 360 subjects ranging in age between 45 and 60 years of age at 13 clinical sites. Subjects were 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 were examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.

The study also included a 60 subject randomized controlled sub-study at 3 investigation sites. Sub-study subjects were randomized (1:1 ratio) to a surgery group or a control group. Subjects randomized to the surgery group underwent surgery and were followed for 24 months in the same manner as the larger non-randomized surgical group. Subjects randomized to the control group were observed for 6 months, and were then eligible to undergo surgery after completion of this 6-month observation period.

The primary endpoint is the 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 is 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.

Safety data analyses were performed and separate summaries are provided for primary and all eyes. Descriptive statistics on the following attributes are provided for; BCDVA, IOP, Slit lamp findings, Fundus exam findings, and Adverse events.

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

Primary outcomes

• Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters. [From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.]: 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.

Secondary outcomes

• 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.]: The randomized surgery group is defined as successful if the percentage of primary eyes achieving Distance Corrected Near Visual Acuity at 40 centimeters of 20/40 of Better and Gain of 10 Letters more at 6 months postoperative (i.e. 6-month responder rate) is higher than the percentage in the randomized control group.

Sex: All, ages: 45 Years to 60 Years, accepts healthy volunteers

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.

Participant flow

Outcome results

• Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters. (Primary), Count of participants, Participants: Overall Study Population 289
• Number of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy (Secondary), Count of participants, Participants: Implantation-Randomized 18; Deferred Implantion-Randomized 2

Adverse events

Time frame: Adverse event reporting continued through 24 months.

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2015-03-03)

• Selene Burke, O.D., Study director, V.P. Clinical Affairs