Presbyopia
Conditions
Keywords
Near Vision, Reading Vision, Reading Glasses, Reading, Readers, Presbyopic
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVisAbility™ 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 in the eye(s) will be followed prospectively.
Sponsors
Refocus Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who were implanted with the VisAbility™ Micro Insert in Protocol VIS-2014
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Measure - Partial or Complete Explantation | 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. | 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. |
| Primary Safety Measure - Anterior Segment Ischemia | 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. | 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. |
| Primary Safety Measure - Segment Exposure. | 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. | Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs. |
| Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | 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. | Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits | From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery. | 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. |
| Secondary Safety Measure - Intraocular Pressure (IOP) | From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery. | IOP increase \> 10 mm Hg over baseline or IOP \> 30 mm Hg as measured via Goldmann applanation tonometry |
| Secondary Safety Measure - Slit Lamp | 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. | Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR |
| Secondary Safety Measure - Fundus Exam | 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. | 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 |
| Secondary Safety Measure - Number of Participants With Adverse Events | 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. | 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 |
| Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | 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. | 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). |
| Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | 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. | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 287 |
| 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. | 565 |
| Total | 852 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missed Visit | 24 |
| Overall Study | Withdrawal by Subject | 44 |
Baseline characteristics
| Characteristic | Implantation or Explantation Safety Cohort |
|---|---|
| Age, Continuous | 51.7 years |
| Astigmatism (D) | -0.285 Diopters STANDARD_DEVIATION 0.289 |
| Best Corrected Distance Visual Acuity (BCDVA-LogMAR) | -0.072 LogMAR STANDARD_DEVIATION 0.065 |
| Bilateral Uncorrected Intermediate Visual Acuity (UCIVA LogMAR) | 0.335 LogMAR STANDARD_DEVIATION 0.151 |
| Corneal Keratometry | 43.664 Diopters STANDARD_DEVIATION 1.371 |
| Cycloplegic Spherical Equivalent (D) | 0.222 Diopters STANDARD_DEVIATION 0.304 |
| Distance Corrected Near Visual Acuity (DCNVA-Logarithm of the Minimum Angle of Resolution(LogMAR)))) | 0.496 LogMAR STANDARD_DEVIATION 0.083 |
| Dominant Eye OD | 190 participants |
| Dominant Eye OS | 97 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 260 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Intraocular Pressure (IOP-mmHg) | 14.7 mmHg STANDARD_DEVIATION 2.6 |
| Manifest Refraction Spherical Equivalent (MRSE-Diopters)) | 0.129 Diopters STANDARD_DEVIATION 0.261 |
| Maximum Pupil Size (mm) | 5.53 millimeters STANDARD_DEVIATION 0.79 |
| Minimum Pupil Size (mm) | 3.18 millimeters STANDARD_DEVIATION 0.56 |
| Near Addition (D) | 1.617 Diopter STANDARD_DEVIATION 0.306 |
| Race/Ethnicity, Customized Asian | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants |
| Race/Ethnicity, Customized Caucasian | 243 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Other | 11 Participants |
| Scleral Thickness | 572.6 microns STANDARD_DEVIATION 44.2 |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 171 Participants |
| Uncorrected Distance Visual Acuity (UCDVA LogMAR) | -0.011 LogMAR STANDARD_DEVIATION 0.091 |
| Uncorrected Near Visual Acuity ((UCNVA-Logarithm of the Minimum Angle of Resolution (LogMAR)) | 0.525 LogMAR STANDARD_DEVIATION 0.084 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 287 |
| other Total, other adverse events | 46 / 287 |
| serious Total, serious adverse events | 4 / 287 |
Outcome results
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.
Time frame: 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.
Population: All eyes that were previously implanted or explanted in the VIS-2014 clinical trial
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Implantation or Explantation Safety Cohort | Primary Safety Measure - Anterior Segment Ischemia | 0 Eyes |
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.
Time frame: 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.
Population: All implanted or explanted eyes in the VIS-2014 clinical study who were subsequently enrolled in the VIS-2014-5YR long term study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Primary Safety Measure - Partial or Complete Explantation | Partial Explant | 2 Eyes |
| Implantation or Explantation Safety Cohort | Primary Safety Measure - Partial or Complete Explantation | Complete Explant | 4 Eyes |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Participants with Ocular Serious Adverse Events | 0 Participants |
| Implantation or Explantation Safety Cohort | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Participants with Non-Ocular Serious Adverse Events | 4 Participants |
| Implantation or Explantation Safety Cohort | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Ischemic Stroke leading to Cortical Left Inferior Homonymous Hemianopsia | 1 Participants |
| Implantation or Explantation Safety Cohort | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | COVID-19 Infection | 1 Participants |
| Implantation or Explantation Safety Cohort | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Hepatic Encephalopathy | 1 Participants |
| Implantation or Explantation Safety Cohort | Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events | Sepsis of Left Lower Leg leading to BKA and Coma | 1 Participants |
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.
Time frame: 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.
Population: All eyes implanted or explanted in the VIS-2014 clinical study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Implantation or Explantation Safety Cohort | Primary Safety Measure - Segment Exposure. | 1 Eyes |
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).
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | Preopeartive DCNVA 20/40 or better | 2 Primary Eyes |
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | 36 months DCNVA 20/40 or better | 149 Primary Eyes |
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | 48 months DCNVA 20/40 or better | 212 Primary Eyes |
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort | 60 months DCNVA 20/40 or better | 161 Primary Eyes |
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).
Time frame: 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.
Population: Number of primary eyes of bilaterally implanted subjects (with all 8 segments in place) present at each visit (preopeartive, 36, 48 and 60 months)
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | Primary Eye UCNVA 20/40 or better at 36 months | 135 Primary Eyes |
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | Primary Eye UCNVA 20/40 or better at 48 months | 174 Primary Eyes |
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | Primary Eye UCNVA 20/40 or better at 60 months | 128 Primary Eyes |
| Implantation or Explantation Safety Cohort | Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort | Primary Eye UCNVA 20/40 or better at baseline | 2 Primary Eyes |
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.
Time frame: From date of enrollment until the date of study withdrawal or study completion, whichever comes first, assessed up to 60 months post-surgery.
Population: BCDVA for all eyes that were implanted or explanted in the VIS-2014 and subseuqently enrolled in the VI-2014-5YR long term study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits | Percentage of eyes achieving BCDVA of 20/20 or better at 36 months postoperative visit | 363 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits | Percentage of eyes with BCDVA of 20/20 or better at 48 months postoperative | 510 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Best Corrected Distance Visual Acuity (BCDVA) in Eyes Examined at 36, 48 and 60 Month Visits | Percentage of eyes achieving BCDVA of 20/20 or better at 60 months postoperative | 330 Eyes |
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
Time frame: 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.
Population: Implanted or explanted eyes in the VIS-2014 clinical study subsequently enrolled in the VIS-2014-5YR study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Age Related Macular Degeneration | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Longstanding Branch Retinal Vein Occlusion | 1 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Central Serous Retinopathy | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Chorioretinal Scars | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Choroidal Nevi | 7 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Cotton Wool Spots | 3 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Peripheral Retinal Degeneration | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Presumed Ocular Histoplasmosis Syndrome (POHS) | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Posterior Vitreous Detachment | 6 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | REtinal Pigment Epithelium changes | 4 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Retinal Pigment Epithelial detachment | 1 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | RPE hyperplasia 2ndary to laser treatment | 1 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Epiretinal Membranes | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Lattice Degeneration | 5 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Microaneurysms | 1 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Fundus Exam | Optic Nerve Pallor 2ndary to stroke or neuropathy | 3 Eyes |
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
Time frame: From date of enrollment until the date of study withdrawal or study completion, whichever came first, assessed up to 60 months post-surgery.
Population: Safety Cohort Consists of all implanted or explanted eyes in the VIS-2014 who enrolled in the VIS-2014-5YR long term study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Intraocular Pressure (IOP) | # of eyes with IOP <6mmHg, or >30mmHg, or an increase in IOP >10mmHg from baseline at 36 month visit | 0 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Intraocular Pressure (IOP) | # of eyes with IOP <6mmHg, or >30mmHg, or an increase in IOP >10mmHg from baseline at 48 month visit | 0 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Intraocular Pressure (IOP) | # of eyes with IOP <6mmHg, or >30mmHg, or an increase in IOP >10mmHg from baseline at 60 month visit | 0 Eyes |
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
Time frame: 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.
Population: Subjects who were either implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR Long Term study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Anterior Segment Ischemia | 0 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Conjunctival Cyst | 3 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Conjunctival Erosion | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Subconjunctival hemorrhage (not associated with an explant, concomitant procedure, etc.) | 5 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Conjunctivitis (allergic, bacterial, viral) | 3 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Scleral Erosion | 0 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Persistent Pupil Abnormality | 0 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Complete Explantation | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Partial Explantation | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Cataract Extraction | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Recurrent Corneal Erosion | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Trichiasis of single lash Right lower lid | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | BCDVA loss greater than or equal to 2 lines | 4 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Lids and Lashes (Chalazion lid margin disease) | 3 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Dry Eye signs requring prescription | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Lens Opacity-2 grade change as compared to preoperative baseline | 7 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Glaucoma | 0 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Posterior Vitreous Detachment-new onset | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Extruded, Misplaced or Missing Segments | 0 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Other 2ndary Surgical Procedure (Clear Lens Exchange or PRK) | 3 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Central Serous Chorioretinopathy | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Chemical Injury | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Cotton Wool Spot | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Dry Eye Symptoms requiring prescription medication | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Epiretinal Membrane | 2 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Foreign Body Sensation | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Lattice Degeneration | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Non Proliferative Diabetic Retinopathy | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Ocular Migraine | 1 Participants |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Number of Participants With Adverse Events | Pyogenic Granuloma | 1 Participants |
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
Time frame: 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.
Population: Eyes implanted or explanted during the VIS-2014 clinical study
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Mild Conjunctival Injection not noted preoperatively | 17 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Subconjunctival hemorrhage of 2 quadrants or less | 7 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Trace Conjunctival Edema | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Conjunctival Cyst | 3 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Conjunctival Scar | 5 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Pyogenic Granuloma | 1 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Anterior Chamber Cell | 0 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Anterior Chamber Flare | 0 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Iris Atrophy | 2 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | 2 Grade change in Lens Opacity | 8 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Mild Superficial Punctate Keratitis | 11 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Corneal Abrasion | 0 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Corneal Edema | 0 Eyes |
| Implantation or Explantation Safety Cohort | Secondary Safety Measure - Slit Lamp | Corneal Endothelial Guttata more than rare | 0 Eyes |