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The objective of this study is to obtain an additional 36 months of safety and effectiveness data from all subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial.
VIS-2014-5YR is a multicenter, observational study to evaluate the long-term safety of the VisAbility™ Micro Inserts in subjects who were implanted with the VisAbility™ Micro Insert in the VIS-2014 clinical trial. Study subjects will be examined at 36, 48, and 60 months post-operatively (based on the anniversary of their first VisAbility™ surgery) with no planned interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation-Non-randomized | Experimental | Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety and effectiveness outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisAbility™ Micro Insert | Device | No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Measure - Partial or Complete Explantation | Partial explantation (surgical removal of 1-3 Micro Inserts per eye), or complete explantation (surgical removal of all 4 Micro inserts per eye), and reason(s). Safety measure will be recorded if the event occurs. | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Primary Safety Measure - Anterior Segment Ischemia | Anterior Segment Ischemia (decreased blood perfusion to the anterior segment of the eye (Grades 2 - 4--the higher the grade, the worse the outcome). Grade 2 is decreased pupil reactivity (<25% of Percent Constriction using Neuroptics Pupillometry) Grade 3 is decreased pupil reactivity, plus anterior chamber reaction of Grade 2 cell and/or flare as assessed via biomicrosope examination Grade 4 is decreased pupil reactivity, plus anterior chamber reaction of Grade 2 cell and/or flare, plus corneal edema (Grade 3 with Striate Keratopathy) as assessed via biomicroscope examination Safety measure will be recorded if the event occurs. | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Primary Safety Measure - Segment Exposure. | Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs. | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs. | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits | Best Corrected Distance Visual Acuity (BCDVA, which is distance visual acuity with the best distance refractive corretion in place) in all eyes seen at the 36 month postoperative visit, 48 month postoperative visit and 60 month postoperative visit will be measured and recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Schanzlin, Dr | Chief Medical Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Vision | Orange | California | 92868 | United States | ||
| Gordon Schanzlin New Vision Institute |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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Per the protocol, primary and secondary safety outcome analysis was performed on all eyes of enrolled subjects that were implanted or explanted with the VisAbility Micro Insert System in the VIS-2014 clinical study. Secondary effectiveness analysis was performed on the primary eye of only those subjects who were bilaterally implanted (with all eight implants in place) in the VIS-2014 study, therefore, the primary eye is the unit of analysis for the secondary effectiveness outcome.
Recruitment occurred at 13 clinical sites and consisted of contacting all subjects who were implanted or explanted in Protocol VIS-2014, a prospective multicenter clinical trial of the VisAbility Micro Insert System. If inclusion criteria was met, subjects who wished to participate provided written informed consent and were enrolled in this VIS-2014-5YR multicenter observational long-term study.
| ID | Title | Description |
|---|---|---|
| FG000 | Implantation or Explantation Safety Cohort | Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted or explanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety outcomes. VisAbility™ Micro Insert: No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted or explanted in the eye(s) will be followed prospectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2018 |
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A non-randomized single group design. All subjects who were implanted with the VisAbility™ Micro Insert (360 subjects) will be invited to participate. Actual sample size will be determined at the completion of enrollment.
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| From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Secondary Safety Measure - Intraocular Pressure (IOP) | IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg as measured via Goldmann applanation tonometry | From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery. |
| Secondary Safety Measure - Slit Lamp | Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Secondary Safety Measure - Fundus Exam | Fundus exam findings (using binocular indirect ophthalmoscopy and/or the biomicroscope/slit lamp and a condensing lens) in all eyes implanted or explanted in the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR study | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Secondary Safety Measure - Number of Participants With Adverse Events | Rate of Adverse Events (AE's) in all participants implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR study | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | distance corrected near visual acuity of 20/40 or better in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014). | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | uncorrected near visual acuity of 20/40 or better in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014). | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
| San Diego |
| California |
| 92122 |
| United States |
| Aloha Laser Vision | Honolulu | Hawaii | 96814 | United States |
| The Midwest Center for Sight | Des Plaines | Illinois | 60016 | United States |
| Eye Surgeons Of Indiana PC | Indianapolis | Indiana | 46260 | United States |
| Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| South Shore Eye Care LLP | Wantagh | New York | 11793 | United States |
| Physicians Protocol | Greensboro | North Carolina | 27401 | United States |
| Comprehensive EyeCare of Central Ohio | Westerville | Ohio | 43082 | United States |
| Bucci Laser Vision | Wilkes-Barre | Pennsylvania | 18702 | United States |
| Key Whitman Eye Center | Dallas | Texas | 75242 | United States |
| Braverman-Terry-Oei-Eye Associates | San Antonio | Texas | 78212 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Implantation or Explantation Safety Cohort | Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted or explanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety outcomes. VisAbility™ Micro Insert: No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted or explanted in the eye(s) will be followed prospectively. |
| Units | Counts |
|---|---|
| Participants |
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| eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years | Participants |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| ||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
| ||||||||||||||||||||||
| Dominant Eye | Number | participants | Participants |
| ||||||||||||||||||||||
| Distance Corrected Near Visual Acuity (DCNVA-Logarithm of the Minimum Angle of Resolution(LogMAR)))) | Preoperative LogMAR Distance Corrected Near Visual Acuity measured at 40cm. This represents the near visual acuity with the distance refractive correction in front of the eye. | Mean | Standard Deviation | LogMAR | eyes |
| ||||||||||||||||||||
| Uncorrected Near Visual Acuity ((UCNVA-Logarithm of the Minimum Angle of Resolution (LogMAR)) | Preoperative LogMAR Uncorrected Near Visual Acuity (UCNVA)at 40cm. This represents the near visual acuity without the distance refraction correction. | Mean | Standard Deviation | LogMAR | eyes |
| ||||||||||||||||||||
| Bilateral Uncorrected Intermediate Visual Acuity (UCIVA LogMAR) | Preoperative LogMAR Bilateral (OU) Uncorrected Intermediate Visual Acuity (66cm). This represents the visual acuity at 66cm while both eyes are viewing without any distance refraction correction in place. | Mean | Standard Deviation | LogMAR | Participants |
| ||||||||||||||||||||
| Uncorrected Distance Visual Acuity (UCDVA LogMAR) | Preoperative LogMAR uncorrected distance visual acuity (6m). This represents the vision in each eye while looking at distance (6 meters) without the distance refractive correction in place. | Mean | Standard Deviation | LogMAR | eyes |
| ||||||||||||||||||||
| Best Corrected Distance Visual Acuity (BCDVA-LogMAR) | Preoperative LogMAR Best Corrected Distance Visual Acuity (6m). This represents the distance visual acuity in each eye with the distance refraction correction in place. | Mean | Standard Deviation | LogMAR | eyes |
| ||||||||||||||||||||
| Manifest Refraction Spherical Equivalent (MRSE-Diopters)) | Preoperative Manifest Refraction Spherical Equivalent in Diopters | Mean | Standard Deviation | Diopters | eyes |
| ||||||||||||||||||||
| Near Addition (D) | Preoperative Near Addition over the distance refractive correction in Diopters required to see 20/20 | Mean | Standard Deviation | Diopter | eyes |
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| Intraocular Pressure (IOP-mmHg) | Preoperative Intraocular Pressure in mmHg | Mean | Standard Deviation | mmHg | eyes |
| ||||||||||||||||||||
| Maximum Pupil Size (mm) | Preoperative maximum (scotopic=dim lighting of dark adapted eyes) pupil size in mm | Mean | Standard Deviation | millimeters | eyes |
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| Minimum Pupil Size (mm) | Preoperative minimum (photopic) pupil size in mm | Mean | Standard Deviation | millimeters | eyes |
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| Astigmatism (D) | Preopeartive Refractive Astigmatism in Diopters | Mean | Standard Deviation | Diopters | eyes |
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| Cycloplegic Spherical Equivalent (D) | Preoperative Spherical Equivalent after cycloplegia in Diopters | Mean | Standard Deviation | Diopters | eyes |
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| Corneal Keratometry | Preoperative Mean Corneal Keratometry (K1+K2)/2 in Diopters | Mean | Standard Deviation | Diopters | eyes |
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| Scleral Thickness | Preoperative Scleral Thickness measured 3.5mm from limbus in the superior temporal quadrant in units of Microns | Mean | Standard Deviation | microns | eyes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Safety Measure - Partial or Complete Explantation | Partial explantation (surgical removal of 1-3 Micro Inserts per eye), or complete explantation (surgical removal of all 4 Micro inserts per eye), and reason(s). Safety measure will be recorded if the event occurs. | All implanted or explanted eyes in the VIS-2014 clinical study who were subsequently enrolled in the VIS-2014-5YR long term study | Posted | Count of Units | Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Eyes | Eyes |
|
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| |||||||||||||||||||||||||||||||||
| Primary | Primary Safety Measure - Anterior Segment Ischemia | Anterior Segment Ischemia (decreased blood perfusion to the anterior segment of the eye (Grades 2 - 4--the higher the grade, the worse the outcome). Grade 2 is decreased pupil reactivity (<25% of Percent Constriction using Neuroptics Pupillometry) Grade 3 is decreased pupil reactivity, plus anterior chamber reaction of Grade 2 cell and/or flare as assessed via biomicrosope examination Grade 4 is decreased pupil reactivity, plus anterior chamber reaction of Grade 2 cell and/or flare, plus corneal edema (Grade 3 with Striate Keratopathy) as assessed via biomicroscope examination Safety measure will be recorded if the event occurs. | All eyes that were previously implanted or explanted in the VIS-2014 clinical trial | Posted | Count of Units | Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Eyes | Eyes |
| |||||||||||||||||||||||||||||||||||
| Primary | Primary Safety Measure - Segment Exposure. | Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs. | All eyes implanted or explanted in the VIS-2014 clinical study. | Posted | Count of Units | Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Eyes | Eyes |
|
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| Primary | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs. | Subjects that were enrolled and implanted or explanted in the VIS-2014 clinical trial and subsequently enrolled in the VIS-2014-5YR long term study. | Posted | Count of Participants | Participants | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
|
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| Secondary | Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits | Best Corrected Distance Visual Acuity (BCDVA, which is distance visual acuity with the best distance refractive corretion in place) in all eyes seen at the 36 month postoperative visit, 48 month postoperative visit and 60 month postoperative visit will be measured and recorded. | BCDVA for all eyes that were implanted or explanted in the VIS-2014 and subseuqently enrolled in the VI-2014-5YR long term study | Posted | Count of Units | Eyes | From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Eyes | Eyes |
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| Secondary | Secondary Safety Measure - Intraocular Pressure (IOP) | IOP increase > 10 mm Hg over baseline or IOP > 30 mm Hg as measured via Goldmann applanation tonometry | Safety Cohort Consists of all implanted or explanted eyes in the VIS-2014 who enrolled in the VIS-2014-5YR long term study | Posted | Count of Units | Eyes | From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery. | Eyes | Eyes |
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| Secondary | Secondary Safety Measure - Slit Lamp | Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR | Eyes implanted or explanted during the VIS-2014 clinical study | Posted | Count of Units | Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Eyes | Eyes |
|
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| Secondary | Secondary Safety Measure - Fundus Exam | Fundus exam findings (using binocular indirect ophthalmoscopy and/or the biomicroscope/slit lamp and a condensing lens) in all eyes implanted or explanted in the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR study | Implanted or explanted eyes in the VIS-2014 clinical study subsequently enrolled in the VIS-2014-5YR study | Posted | Count of Units | Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Eyes | Eyes |
|
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| Secondary | Secondary Safety Measure - Number of Participants With Adverse Events | Rate of Adverse Events (AE's) in all participants implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR study | Subjects who were either implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR Long Term study | Posted | Count of Participants | Participants | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. |
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| Secondary | Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | distance corrected near visual acuity of 20/40 or better in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014). | Primary eyes of subjects who were bilaterally implanted during the VIS-2014 clinical study, were subsequently enrolled in the VIS-2014-5YR study and have all 8 segments in place. | Posted | Count of Units | Primary Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Primary Eyes | Primary Eyes |
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| Secondary | Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | uncorrected near visual acuity of 20/40 or better in the primary eye of bilaterally implanted subjects (with all eight implants in place), as compared to baseline (VIS-2014). | Number of primary eyes of bilaterally implanted subjects (with all 8 segments in place) present at each visit (preopeartive, 36, 48 and 60 months) | Posted | Count of Units | Primary Eyes | From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | Primary Eyes | Primary Eyes |
|
|
From date of VIS-2014-5YR enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implantation or Explantation Safety Cohort | Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted or explanted in the eye(s) will be followed prospectively for an additional 36 month period to measure long term safety outcomes. VisAbility™ Micro Insert: No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted or explanted in the eye(s) will be followed prospectively. | 0 | 287 | 4 | 287 | 46 | 287 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischemic Stroke w/ 2ndary Cortical Left Inferior Homonymous Hemianopsia | Nervous system disorders | Systematic Assessment | Non-Ocular Non-Device Related Serious Adverse Event |
| |
| COVID-19 Infection | Infections and infestations | Systematic Assessment | Non-Ocular, Non-Device Related Serious Adverse Event |
| |
| Hepatic Encephalopathy | Hepatobiliary disorders | Systematic Assessment | Non-Ocular Non-Device Related Serious Adverse Event |
| |
| Sepsis of the Left Lower Leg leading to BKA and Coma | Infections and infestations | Systematic Assessment | Non-Ocular Non-Device related Serious Adverse Event |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decrease in BCDVA of greater than or equal to 2 lines | Eye disorders | Systematic Assessment | Decrease in BCDVA of greater than or equal to 2 lines |
| |
| Chalazion/Lid Margin Disease | Eye disorders | Systematic Assessment | Chalazion, or onset of or worsening to severe, clinically signficant lid margin disease |
| |
| Dry Eye signs requiring prescription | Eye disorders | Systematic Assessment | Dry Eye signs requiring prescription medication |
| |
| Conjunctival Cyst | Eye disorders | Systematic Assessment | Conjunctival Cyst |
| |
| Conjunctival Erosion | Eye disorders | Systematic Assessment | Conjunctival Erosion |
| |
| Subconjunctival hemorrhage | Eye disorders | Systematic Assessment | Subconjunctival hemorrhage not associated wtih an explant, concomitant procedure, etc. |
| |
| Conjunctivitis | Eye disorders | Systematic Assessment | Conjunctivitis (allergic, bacterial, or viral) |
| |
| Lens Opacity | Eye disorders | Systematic Assessment | Lens Opacity--2 grade change as compared to preoperative baseline |
| |
| Posterior Vitreous Detachment | Eye disorders | Systematic Assessment | Posterior Vitreous Detachment |
| |
| Secondary Surgical Intervention-Complete Explant | Eye disorders | Systematic Assessment | Explant of all 4 segments or all remaining segments from eye |
| |
| Secondary Surgical Intervention-Partial Explant | Eye disorders | Systematic Assessment | Individual or multiple segments removed with at least 1 remaining segment |
| |
| Secondary Surgical Intervention-Cataract Extraction | Eye disorders | Systematic Assessment | Cataract Extractiion |
| |
| Other Surgical Intervention | Eye disorders | Systematic Assessment | Other Surgical interventon--clear lens extraction, photorefractive keratectomy |
| |
| Central Serous Chorioretinopathy | Eye disorders | Systematic Assessment | Central Serous Chorioretinopathy |
| |
| Chemical Injury | Injury, poisoning and procedural complications | Systematic Assessment | non-devic, non-procedure related ocular chemical injury |
| |
| cotton wool spot | Eye disorders | Systematic Assessment | retinal finding associated with systemic hypertension |
| |
| Dry Eye Symptoms requiring prescription medication | Eye disorders | Systematic Assessment | Patient reports of dry eye symptoms despite no clinical signs of dry eye--prescription medication was prescribed |
| |
| Epiretinal membrane | Eye disorders | Systematic Assessment | Epiretinal membrane |
| |
| Foreign Body Sensation | Eye disorders | Systematic Assessment | Ocular Foreign Body Sensation |
| |
| Lattice Degeneration | Eye disorders | Systematic Assessment | Lattice Degeneration |
| |
| Non-Proliferative Diabetic Retinopathy | Endocrine disorders | Systematic Assessment | Non-device related finding associated with systemic diabetes |
| |
| Ocular Migraine | Vascular disorders | Systematic Assessment | Ocular Migraine |
| |
| Pyogenic Granuloma | Eye disorders | Systematic Assessment | Pyogenic Granuloma |
| |
| Recurrent Corneal Erosion | Eye disorders | Systematic Assessment | Injury related recurrent corneal erosion, not device or procedure related |
| |
| Trichiasis of single lash right lower lid | Eye disorders | Systematic Assessment | Not device/procedure related |
|
Delay in VIS-2014-5YR approval and initiation resulted in some of the participants falling outside the 36 month window at the time of study commencement.
COVID shutdowns affected study accountability.
The Sponsor encourages publication and presentation of the safety and effectiveness results upon completion of the study. Per the established investigator agreement, the Principal Investigators will work with the Sponsor, in good faith, to ensure all confidential and proprietary informaton is redacted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Stewart, Director of Regulatory and Quality | Refocus Group, Inc. | 214-368-0200 | 431 | lstewart@refocus-group.com |
| Oct 24, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Caucasian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Units | Counts |
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| Eyes |
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| Eyes |
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| Primary Eyes |
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| Primary Eyes |
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