Trial Outcomes & Findings for Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients (NCT NCT03811249)
NCT ID: NCT03811249
Last Updated: 2023-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
287 participants
Primary outcome timeframe
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.
Results posted on
2023-11-18
Participant Flow
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.
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.
Unit of analysis: Eye
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
287 565
|
|
Overall Study
COMPLETED
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219 433
|
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Overall Study
NOT COMPLETED
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68 132
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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44
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Overall Study
Missed Visit
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24
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Baseline Characteristics
Long Term Follow-up of the VisAbility™ Micro Insert System for Presbyopic Patients
Baseline characteristics by cohort
| Measure |
Implantation or Explantation Safety Cohort
n=565 eyes
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.
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|---|---|
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Age, Continuous
|
51.7 years
n=5 Participants
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Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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260 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
|
16 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
243 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
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Dominant Eye
OD
|
190 participants
n=5 Participants
|
|
Dominant Eye
OS
|
97 participants
n=5 Participants
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Distance Corrected Near Visual Acuity (DCNVA-Logarithm of the Minimum Angle of Resolution(LogMAR))))
|
0.496 LogMAR
STANDARD_DEVIATION 0.083 • n=32 eyes
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Uncorrected Near Visual Acuity ((UCNVA-Logarithm of the Minimum Angle of Resolution (LogMAR))
|
0.525 LogMAR
STANDARD_DEVIATION 0.084 • n=32 eyes
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Bilateral Uncorrected Intermediate Visual Acuity (UCIVA LogMAR)
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0.335 LogMAR
STANDARD_DEVIATION 0.151 • n=5 Participants
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Uncorrected Distance Visual Acuity (UCDVA LogMAR)
|
-0.011 LogMAR
STANDARD_DEVIATION 0.091 • n=32 eyes
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Best Corrected Distance Visual Acuity (BCDVA-LogMAR)
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-0.072 LogMAR
STANDARD_DEVIATION 0.065 • n=32 eyes
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|
Manifest Refraction Spherical Equivalent (MRSE-Diopters))
|
0.129 Diopters
STANDARD_DEVIATION 0.261 • n=32 eyes
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Near Addition (D)
|
1.617 Diopter
STANDARD_DEVIATION 0.306 • n=32 eyes
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|
Intraocular Pressure (IOP-mmHg)
|
14.7 mmHg
STANDARD_DEVIATION 2.6 • n=32 eyes
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Maximum Pupil Size (mm)
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5.53 millimeters
STANDARD_DEVIATION 0.79 • n=32 eyes
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|
Minimum Pupil Size (mm)
|
3.18 millimeters
STANDARD_DEVIATION 0.56 • n=32 eyes
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Astigmatism (D)
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-0.285 Diopters
STANDARD_DEVIATION 0.289 • n=32 eyes
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Cycloplegic Spherical Equivalent (D)
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0.222 Diopters
STANDARD_DEVIATION 0.304 • n=32 eyes
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Corneal Keratometry
|
43.664 Diopters
STANDARD_DEVIATION 1.371 • n=32 eyes
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Scleral Thickness
|
572.6 microns
STANDARD_DEVIATION 44.2 • n=32 eyes
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PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=287 Participants
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.
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|---|---|
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Primary Safety Measure - Partial or Complete Explantation
Partial Explant
|
2 Eyes
|
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Primary Safety Measure - Partial or Complete Explantation
Complete Explant
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4 Eyes
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PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=565 Eyes
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.
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|---|---|
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Primary Safety Measure - Anterior Segment Ischemia
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0 Eyes
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PRIMARY outcome
Timeframe: 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.
Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs.
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=565 Eyes
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.
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Primary Safety Measure - Segment Exposure.
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1 Eyes
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PRIMARY outcome
Timeframe: 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.
Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=287 Participants
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.
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Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Participants with Ocular Serious Adverse Events
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0 Participants
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Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Participants with Non-Ocular Serious Adverse Events
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4 Participants
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|
Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Ischemic Stroke leading to Cortical Left Inferior Homonymous Hemianopsia
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1 Participants
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Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
COVID-19 Infection
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1 Participants
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Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Hepatic Encephalopathy
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1 Participants
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Primary Safety Measure -Participants With Serious Ocular and Serious Non-Ocular Adverse Events
Sepsis of Left Lower Leg leading to BKA and Coma
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1 Participants
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SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=565 Eyes
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.
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|---|---|
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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
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363 Eyes
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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
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510 Eyes
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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
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330 Eyes
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SECONDARY outcome
Timeframe: 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
IOP increase \> 10 mm Hg over baseline or IOP \> 30 mm Hg as measured via Goldmann applanation tonometry
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=565 Eyes
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.
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|---|---|
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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
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0 Eyes
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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
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0 Eyes
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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
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SECONDARY outcome
Timeframe: 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
Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=565 Eyes
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.
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Secondary Safety Measure - Slit Lamp
Mild Superficial Punctate Keratitis
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11 Eyes
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Secondary Safety Measure - Slit Lamp
Corneal Abrasion
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0 Eyes
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Secondary Safety Measure - Slit Lamp
Corneal Edema
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0 Eyes
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Secondary Safety Measure - Slit Lamp
Corneal Endothelial Guttata more than rare
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0 Eyes
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Secondary Safety Measure - Slit Lamp
Mild Conjunctival Injection not noted preoperatively
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17 Eyes
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Secondary Safety Measure - Slit Lamp
Subconjunctival hemorrhage of 2 quadrants or less
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7 Eyes
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Secondary Safety Measure - Slit Lamp
Trace Conjunctival Edema
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2 Eyes
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Secondary Safety Measure - Slit Lamp
Conjunctival Cyst
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3 Eyes
|
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Secondary Safety Measure - Slit Lamp
Conjunctival Scar
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5 Eyes
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Secondary Safety Measure - Slit Lamp
Pyogenic Granuloma
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1 Eyes
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Secondary Safety Measure - Slit Lamp
Anterior Chamber Cell
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0 Eyes
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Secondary Safety Measure - Slit Lamp
Anterior Chamber Flare
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0 Eyes
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Secondary Safety Measure - Slit Lamp
Iris Atrophy
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2 Eyes
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Secondary Safety Measure - Slit Lamp
2 Grade change in Lens Opacity
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8 Eyes
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SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=565 Eyes
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.
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|---|---|
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Secondary Safety Measure - Fundus Exam
Age Related Macular Degeneration
|
2 Eyes
|
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Secondary Safety Measure - Fundus Exam
Longstanding Branch Retinal Vein Occlusion
|
1 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Central Serous Retinopathy
|
2 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Chorioretinal Scars
|
2 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Choroidal Nevi
|
7 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Cotton Wool Spots
|
3 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Epiretinal Membranes
|
2 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Lattice Degeneration
|
5 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Microaneurysms
|
1 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Optic Nerve Pallor 2ndary to stroke or neuropathy
|
3 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Peripheral Retinal Degeneration
|
2 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Presumed Ocular Histoplasmosis Syndrome (POHS)
|
2 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Posterior Vitreous Detachment
|
6 Eyes
|
|
Secondary Safety Measure - Fundus Exam
REtinal Pigment Epithelium changes
|
4 Eyes
|
|
Secondary Safety Measure - Fundus Exam
Retinal Pigment Epithelial detachment
|
1 Eyes
|
|
Secondary Safety Measure - Fundus Exam
RPE hyperplasia 2ndary to laser treatment
|
1 Eyes
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=287 Participants
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.
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|---|---|
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Secondary Safety Measure - Number of Participants With Adverse Events
BCDVA loss greater than or equal to 2 lines
|
4 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Lids and Lashes (Chalazion lid margin disease)
|
3 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Dry Eye signs requring prescription
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Conjunctival Cyst
|
3 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Conjunctival Erosion
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Subconjunctival hemorrhage (not associated with an explant, concomitant procedure, etc.)
|
5 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Conjunctivitis (allergic, bacterial, viral)
|
3 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Scleral Erosion
|
0 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Persistent Pupil Abnormality
|
0 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Anterior Segment Ischemia
|
0 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Lens Opacity-2 grade change as compared to preoperative baseline
|
7 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Glaucoma
|
0 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Posterior Vitreous Detachment-new onset
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Extruded, Misplaced or Missing Segments
|
0 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Complete Explantation
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Partial Explantation
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Cataract Extraction
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Other 2ndary Surgical Procedure (Clear Lens Exchange or PRK)
|
3 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Central Serous Chorioretinopathy
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Chemical Injury
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Cotton Wool Spot
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Dry Eye Symptoms requiring prescription medication
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Epiretinal Membrane
|
2 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Foreign Body Sensation
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Lattice Degeneration
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Non Proliferative Diabetic Retinopathy
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Ocular Migraine
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Pyogenic Granuloma
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Recurrent Corneal Erosion
|
1 Participants
|
|
Secondary Safety Measure - Number of Participants With Adverse Events
Trichiasis of single lash Right lower lid
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=262 Primary Eyes
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.
|
|---|---|
|
Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort
Preopeartive DCNVA 20/40 or better
|
2 Primary Eyes
|
|
Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort
36 months DCNVA 20/40 or better
|
149 Primary Eyes
|
|
Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort
48 months DCNVA 20/40 or better
|
212 Primary Eyes
|
|
Secondary Effectiveness Measure - Distance Corrected Near Visual Acuity--Effectiveness Cohort
60 months DCNVA 20/40 or better
|
161 Primary Eyes
|
SECONDARY outcome
Timeframe: 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)
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).
Outcome measures
| Measure |
Implantation or Explantation Safety Cohort
n=262 Primary Eyes
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.
|
|---|---|
|
Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort
Primary Eye UCNVA 20/40 or better at baseline
|
2 Primary Eyes
|
|
Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort
Primary Eye UCNVA 20/40 or better at 36 months
|
135 Primary Eyes
|
|
Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort
Primary Eye UCNVA 20/40 or better at 48 months
|
174 Primary Eyes
|
|
Secondary Effectiveness Measure--Uncorrected Near Visual Acuity-Effectivness Cohort
Primary Eye UCNVA 20/40 or better at 60 months
|
128 Primary Eyes
|
Adverse Events
Implantation or Explantation Safety Cohort
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Implantation or Explantation Safety Cohort
n=287 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Ischemic Stroke w/ 2ndary Cortical Left Inferior Homonymous Hemianopsia
|
0.35%
1/287 • Number of events 1 • 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
|
|
Infections and infestations
COVID-19 Infection
|
0.35%
1/287 • Number of events 1 • 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
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
0.35%
1/287 • Number of events 1 • 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
|
|
Infections and infestations
Sepsis of the Left Lower Leg leading to BKA and Coma
|
0.35%
1/287 • Number of events 1 • 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
|
Other adverse events
| Measure |
Implantation or Explantation Safety Cohort
n=287 participants at risk
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.
|
|---|---|
|
Eye disorders
Decrease in BCDVA of greater than or equal to 2 lines
|
1.4%
4/287 • Number of events 5 • 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
|
|
Eye disorders
Chalazion/Lid Margin Disease
|
1.0%
3/287 • Number of events 4 • 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
|
|
Eye disorders
Dry Eye signs requiring prescription
|
0.70%
2/287 • Number of events 4 • 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
|
|
Eye disorders
Conjunctival Cyst
|
1.0%
3/287 • Number of events 3 • 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
|
|
Eye disorders
Conjunctival Erosion
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
Subconjunctival hemorrhage
|
1.7%
5/287 • Number of events 6 • 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
|
|
Eye disorders
Conjunctivitis
|
1.0%
3/287 • Number of events 6 • 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
|
|
Eye disorders
Lens Opacity
|
2.4%
7/287 • Number of events 8 • 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
|
|
Eye disorders
Posterior Vitreous Detachment
|
0.70%
2/287 • Number of events 2 • 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
|
|
Eye disorders
Secondary Surgical Intervention-Complete Explant
|
0.70%
2/287 • Number of events 4 • 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
|
|
Eye disorders
Secondary Surgical Intervention-Partial Explant
|
0.70%
2/287 • Number of events 2 • 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
|
|
Eye disorders
Secondary Surgical Intervention-Cataract Extraction
|
0.70%
2/287 • Number of events 3 • 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
|
|
Eye disorders
Other Surgical Intervention
|
1.0%
3/287 • Number of events 5 • 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
|
|
Eye disorders
Central Serous Chorioretinopathy
|
0.70%
2/287 • Number of events 2 • 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
|
|
Injury, poisoning and procedural complications
Chemical Injury
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
cotton wool spot
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
Dry Eye Symptoms requiring prescription medication
|
1.4%
4/287 • Number of events 4 • 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
|
|
Eye disorders
Epiretinal membrane
|
0.70%
2/287 • Number of events 2 • 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
|
|
Eye disorders
Foreign Body Sensation
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
Lattice Degeneration
|
0.70%
2/287 • Number of events 2 • 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
|
|
Endocrine disorders
Non-Proliferative Diabetic Retinopathy
|
0.35%
1/287 • Number of events 1 • 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
|
|
Vascular disorders
Ocular Migraine
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
Pyogenic Granuloma
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
Recurrent Corneal Erosion
|
0.35%
1/287 • Number of events 1 • 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
|
|
Eye disorders
Trichiasis of single lash right lower lid
|
0.35%
1/287 • Number of events 1 • 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
|
Additional Information
Linda Stewart, Director of Regulatory and Quality
Refocus Group, Inc.
Phone: 214-368-0200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER