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

Sponsor
Refocus Group, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02374671
Collaborator
(none)
365
Enrollment
14
Locations
3
Arms
40.9
Actual Duration (Months)
26.1
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Device: VisAbility Micro Insert
N/A

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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
365 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
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
Actual Study Start Date :
Nov 15, 2014
Actual Primary Completion Date :
Apr 13, 2018
Actual Study Completion Date :
Apr 13, 2018

Arms and Interventions

ArmIntervention/Treatment
Experimental: Implantation-Non-Randomized

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

Experimental: Implantation-Randomized

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

No Intervention: Deferred Implantation-Randomized

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Coastal VisionOrangeCaliforniaUnited States92868
2Gordon Weiss Vision InstituteSan DiegoCaliforniaUnited States92122
3Aloha Laser VisionHonoluluHawaiiUnited States96814
4The Midwest Center for SightDes PlainesIllinoisUnited States60016
5Eye Surgeons Of Indiana PCIndianapolisIndianaUnited States46256
6Eye Care InstituteLouisvilleKentuckyUnited States40206
7Chu Vision InstituteBloomingtonMinnesotaUnited States55420
8South Shore Eye Care LLPWantaghNew YorkUnited States11793
9South Shore Eye Care, LLPWantaghNew YorkUnited States11793
10Physicians ProtocolGreensboroNorth CarolinaUnited States27401
11Comprehensive EyeCare of Central OhioWestervilleOhioUnited States43082
12Bucci Laser VisionWilkes-BarrePennsylvaniaUnited States18702
13Key Whitman Eye CenterDallasTexasUnited States75242
14Braverman-Terry-Oei Eye AssociatesSan AntonioTexasUnited States78212

Sponsors and Collaborators

  • Refocus Group, Inc.

Investigators

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

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Refocus Group, Inc.
ClinicalTrials.gov Identifier:
NCT02374671
Other Study ID Numbers:
  • VIS-2014
First Posted:
Mar 2, 2015
Last Update Posted:
Jan 6, 2020
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Refocus Group, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsThe prospective, multicenter clinical trial of the VisAbility micro insert was conducted at 13 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.
Pre-assignment DetailOnce determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.
Arm/Group TitleImplantation-Non-RandomziedImplantation-RandomizedDeferred Implantion-Randomized
Arm/Group DescriptionSubjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria. VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.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. VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.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.
Period Title: Observation (Deferred Implantation)
STARTED0031
COMPLETED0026
NOT COMPLETED005
Period Title: Observation (Deferred Implantation)
STARTED3062826
COMPLETED2812723
NOT COMPLETED2513

Baseline Characteristics

Arm/Group TitleImplantation-Non-RandomizedImplantation-RandomizedDeferred Implantion-RandomizedTotal
Arm/Group DescriptionSubjects are not participants in the randomized sub-study. VisAbility micro inserts surgically implanted in the eye(s) after enrollment and meeting inclusion/exclusion criteria. VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.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. VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.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.Total of all reporting groups
Overall Participants3062826360
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
51.8
50.1
51.0
51.6
Sex: Female, Male (Count of Participants)
Female
124
40.5%
10
35.7%
9
34.6%
143
39.7%
Male
182
59.5%
18
64.3%
17
65.4%
217
60.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
20
6.5%
9
32.1%
9
34.6%
38
10.6%
Not Hispanic or Latino
283
92.5%
19
67.9%
17
65.4%
319
88.6%
Unknown or Not Reported
3
1%
0
0%
0
0%
3
0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
17
5.6%
1
3.6%
0
0%
18
5%
Native Hawaiian or Other Pacific Islander
4
1.3%
0
0%
0
0%
4
1.1%
Black or African American
14
4.6%
0
0%
1
3.8%
15
4.2%
White
262
85.6%
23
82.1%
22
84.6%
307
85.3%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
9
2.9%
4
14.3%
3
11.5%
16
4.4%
Region of Enrollment (Count of Participants)
United States
306
100%
28
100%
26
100%
360
100%
DCNVA 20/40 or Better (at baseline) (Count of Participants)
Count of Participants [Participants]
0
0%
0
0%
2
7.7%
2
0.6%

Outcome Measures

1. Primary Outcome
TitleNumber of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters.
DescriptionMeasurement 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.
Time FrameFrom date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.

Outcome Measure Data

Analysis Population Description
Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.
Arm/Group TitleOverall Study Population
Arm/Group DescriptionA total of 360 subjects at 14 sites received implantation of VisiAbility micro inserts and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the micro inserts.
Measure Participants344
Count of Participants [Participants]
289
94.4%
2. Secondary Outcome
TitleNumber of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy
DescriptionThe 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.
Time FrameFrom date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleImplantation-RandomizedDeferred Implantion-Randomized
Arm/Group DescriptionSubjects 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. VisAbility Micro Insert: Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.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.
Measure Participants2829
Count of Participants [Participants]
18
5.9%
2
7.1%

Adverse Events

Time FrameAdverse event reporting continued through 24 months.
Adverse Event Reporting Description An Adverse Event ("AE") is any untoward sign, symptom or disease observed during the course of the study regardless of the suspected cause. Conditions or diseases that are pre-existing or chronic but stable are not Adverse Events. Changes in pre-existing or chronic conditions or diseases that are consistent with natural disease progression are not Adverse Events.
Arm/Group TitleVisAbility Micro Insert Implantation - Single Arm
Arm/Group DescriptionFor post-implant safety analysis, the Implantation-Non Randomized, Implantation-Randomized, and Deferred Implantation-Randomized arms were combined into (one) safety cohort (306 subjects + 26 subjects + 28 subjects, respectively), per protocol. All 360 implanted subjects that received the VisAbility Micro Insert implantation were followed for 24 months and were not analyzed separately. I.e. Subjects who participated in the randomized sub-study crossed over into a single (safety) arm at the time of implantation. For safety analysis and adverse event reporting, all implanted subjects were considered one cohort as there was no difference in treatment nor follow-up after VisAbility Micro Insert implantation.
All Cause Mortality
VisAbility Micro Insert Implantation - Single Arm
Affected / at Risk (%)# Events
Total0/360 (0%)
Serious Adverse Events
VisAbility Micro Insert Implantation - Single Arm
Affected / at Risk (%)# Events
Total4/360 (1.1%)
Eye disorders
Serious Ocular Adverse Events0/360 (0%) 0
General disorders
Serious Non-Ocular Adverse Events4/360 (1.1%) 4
Other (Not Including Serious) Adverse Events
VisAbility Micro Insert Implantation - Single Arm
Affected / at Risk (%)# Events
Total170/360 (47.2%)
Eye disorders
Visual Acuity9/360 (2.5%) 10
Lid33/360 (9.2%) 64
Cornea/Conjunctiva89/360 (24.7%) 159
Iris/Pupil1/360 (0.3%) 1
Anterior Chamber8/360 (2.2%) 9
Lens2/360 (0.6%) 3
Sclera (Intraoperative Events)8/360 (2.2%) 8
Intraocular Pressure6/360 (1.7%) 6
Fundus/Posterior Pole3/360 (0.8%) 3
Other50/360 (13.9%) 70
Surgical and medical procedures
Secondary Surgical Intervention23/360 (6.4%) 28
Allergic Reactions to Medications2/360 (0.6%) 4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal Investigators are NOT employed by the organization sponsoring the study. The Sponsor encourages publication and presentation of the safety and effectiveness results upon completion of the study. Per the established agreement, the Principal Investigators will work with the Sponsor, in good faith, to ensure all confidential and proprietary information is redacted.

Results Point of Contact

Name/TitleDirector of Regulatory & Quality
OrganizationRefocus Group, Inc.
Phone214-368-0200 ext 431
Emaillstewart@refocus-group.com
Responsible Party:
Refocus Group, Inc.
ClinicalTrials.gov Identifier:
NCT02374671
Other Study ID Numbers:
  • VIS-2014
First Posted:
Mar 2, 2015
Last Update Posted:
Jan 6, 2020
Last Verified:
Dec 1, 2019