An interventional study of VisAbility™ Micro Insert in Presbyopia, sponsored by Refocus Group, Inc.. Completed at 13 sites in United States. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Refocus Group, Inc. · Not applicable, Interventional, and Treatment
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.
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 287 is above the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Refocus Group, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: 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 in the eye(s) will be followed prospectively.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Milestone | Implantation or Explantation Safety Cohort |
|---|---|
| Started | 287 |
| Completed | 219 |
| Not completed | 68 |
| Withdrew: Withdrawal by subject | 44 |
| Withdrew: Missed visit | 24 |
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.
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| Partial Explant | 2 |
| Complete Explant | 4 |
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.
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| Primary Safety Measure - Anterior Segment Ischemia | 0 |
Segment exposure due to conjunctival and/or scleral erosion as assessed via biomicroscopic examination. Safety measure will be recorded if the event occurs.
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| Primary Safety Measure - Segment Exposure. | 1 |
Rate of Individual Participants with Serious Ocular and Serious Non-Ocular Adverse Events (SAE's). Safety measure will be recorded if the event occurs.
| Participants | Implantation or Explantation Safety Cohort |
|---|---|
| Participants with Ocular Serious Adverse Events | 0 |
| Participants with Non-Ocular Serious Adverse Events | 4 |
| Ischemic Stroke leading to Cortical Left Inferior Homonymous Hemianopsia | 1 |
| COVID-19 Infection | 1 |
| Hepatic Encephalopathy | 1 |
| Sepsis of Left Lower Leg leading to BKA and Coma | 1 |
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.
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| Percentage of eyes achieving BCDVA of 20/20 or better at 36 months postoperative visit | 363 |
| Percentage of eyes with BCDVA of 20/20 or better at 48 months postoperative | 510 |
| Percentage of eyes achieving BCDVA of 20/20 or better at 60 months postoperative | 330 |
IOP increase \> 10 mm Hg over baseline or IOP \> 30 mm Hg as measured via Goldmann applanation tonometry
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| # of eyes with IOP <6mmHg, or >30mmHg, or an increase in IOP >10mmHg from baseline at 36 month visit | 0 |
| # of eyes with IOP <6mmHg, or >30mmHg, or an increase in IOP >10mmHg from baseline at 48 month visit | 0 |
| # of eyes with IOP <6mmHg, or >30mmHg, or an increase in IOP >10mmHg from baseline at 60 month visit | 0 |
Slit Lamp findings in all eyes implanted or explanted during the VIS-2014 clinical study and subsequently enrolled in the VIS-2014-5YR
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| Mild Superficial Punctate Keratitis | 11 |
| Corneal Abrasion | 0 |
| Corneal Edema | 0 |
| Corneal Endothelial Guttata more than rare | 0 |
| Mild Conjunctival Injection not noted preoperatively | 17 |
| Subconjunctival hemorrhage of 2 quadrants or less | 7 |
| Trace Conjunctival Edema | 2 |
| Conjunctival Cyst | 3 |
| Conjunctival Scar | 5 |
| Pyogenic Granuloma | 1 |
| Anterior Chamber Cell | 0 |
| Anterior Chamber Flare | 0 |
| Iris Atrophy | 2 |
| 2 Grade change in Lens Opacity | 8 |
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
| Eyes | Implantation or Explantation Safety Cohort |
|---|---|
| Age Related Macular Degeneration | 2 |
| Longstanding Branch Retinal Vein Occlusion | 1 |
| Central Serous Retinopathy | 2 |
| Chorioretinal Scars | 2 |
| Choroidal Nevi | 7 |
| Cotton Wool Spots | 3 |
| Epiretinal Membranes | 2 |
| Lattice Degeneration | 5 |
| Microaneurysms | 1 |
| Optic Nerve Pallor 2ndary to stroke or neuropathy | 3 |
| Peripheral Retinal Degeneration | 2 |
| Presumed Ocular Histoplasmosis Syndrome (POHS) | 2 |
| Posterior Vitreous Detachment | 6 |
| REtinal Pigment Epithelium changes | 4 |
| Retinal Pigment Epithelial detachment | 1 |
| RPE hyperplasia 2ndary to laser treatment | 1 |
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
| Participants | Implantation or Explantation Safety Cohort |
|---|---|
| BCDVA loss greater than or equal to 2 lines | 4 |
| Lids and Lashes (Chalazion lid margin disease) | 3 |
| Dry Eye signs requring prescription | 2 |
| Conjunctival Cyst | 3 |
| Conjunctival Erosion | 1 |
| Subconjunctival hemorrhage (not associated with an explant, concomitant procedure, etc.) | 5 |
| Conjunctivitis (allergic, bacterial, viral) | 3 |
| Scleral Erosion | 0 |
| Persistent Pupil Abnormality | 0 |
| Anterior Segment Ischemia | 0 |
| Lens Opacity-2 grade change as compared to preoperative baseline | 7 |
| Glaucoma | 0 |
| Posterior Vitreous Detachment-new onset | 2 |
| Extruded, Misplaced or Missing Segments | 0 |
| Complete Explantation | 2 |
| Partial Explantation | 2 |
| Cataract Extraction | 2 |
| Other 2ndary Surgical Procedure (Clear Lens Exchange or PRK) | 3 |
| Central Serous Chorioretinopathy | 2 |
| Chemical Injury | 1 |
| Cotton Wool Spot | 1 |
| Dry Eye Symptoms requiring prescription medication | 2 |
| Epiretinal Membrane | 2 |
| Foreign Body Sensation | 1 |
| Lattice Degeneration | 1 |
| Non Proliferative Diabetic Retinopathy | 1 |
| Ocular Migraine | 1 |
| Pyogenic Granuloma | 1 |
| Recurrent Corneal Erosion | 1 |
| Trichiasis of single lash Right lower lid | 1 |
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 | Effectiveness Cohort |
|---|---|
| Preopeartive DCNVA 20/40 or better | 2 |
| 36 months DCNVA 20/40 or better | 149 |
| 48 months DCNVA 20/40 or better | 212 |
| 60 months DCNVA 20/40 or better | 161 |
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).
| Primary Eyes | Effectiveness Cohort |
|---|---|
| Primary Eye UCNVA 20/40 or better at baseline | 2 |
| Primary Eye UCNVA 20/40 or better at 36 months | 135 |
| Primary Eye UCNVA 20/40 or better at 48 months | 174 |
| Primary Eye UCNVA 20/40 or better at 60 months | 128 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Implantation or Explantation Safety Cohort | 0/287 (0%) | 4/287 (1.4%) | 46/287 (16%) |
| Event | Implantation or Explantation Safety Cohort |
|---|---|
| Ischemic Stroke w/ 2ndary Cortical Left Inferior Homonymous HemianopsiaNervous system disorders | 1/287 |
| COVID-19 InfectionInfections and infestations | 1/287 |
| Hepatic EncephalopathyHepatobiliary disorders | 1/287 |
| Sepsis of the Left Lower Leg leading to BKA and ComaInfections and infestations | 1/287 |
| Event | Implantation or Explantation Safety Cohort |
|---|---|
| Lens OpacityEye disorders | 7/287 |
| Subconjunctival hemorrhageEye disorders | 5/287 |
| Decrease in BCDVA of greater than or equal to 2 linesEye disorders | 4/287 |
| Dry Eye Symptoms requiring prescription medicationEye disorders | 4/287 |
| Chalazion/Lid Margin DiseaseEye disorders | 3/287 |
| Conjunctival CystEye disorders | 3/287 |
| ConjunctivitisEye disorders | 3/287 |
| Other Surgical InterventionEye disorders | 3/287 |
| Dry Eye signs requiring prescriptionEye disorders | 2/287 |
| Posterior Vitreous DetachmentEye disorders | 2/287 |
| Age, Continuous(years) | Implantation or Explantation Safety Cohort |
|---|---|
| Mean | 51.7 (45 to 60) |
| Sex: Female, Male(Participants) | Implantation or Explantation Safety Cohort |
|---|---|
| Female | 116 |
| Male | 171 |
| Ethnicity (NIH/OMB)(Participants) | Implantation or Explantation Safety Cohort |
|---|---|
| Hispanic or Latino | 24 |
| Not Hispanic or Latino | 260 |
| Unknown or Not Reported | 3 |
| Race/Ethnicity, Customized(Participants) | Implantation or Explantation Safety Cohort |
|---|---|
| Asian | 16 |
| Black or African American | 13 |
| Caucasian | 243 |
| Native Hawaiian or Other Pacific Islander | 4 |
| Other | 11 |
| Dominant Eye(participants) | Implantation or Explantation Safety Cohort |
|---|---|
| OD | 190 |
| OS | 97 |
| Distance Corrected Near Visual Acuity (DCNVA-Logarithm of the Minimum Angle of Resolution(LogMAR))))(LogMAR) | Implantation or Explantation Safety Cohort |
|---|---|
| Mean | 0.496 ± 0.083 |
| Uncorrected Near Visual Acuity ((UCNVA-Logarithm of the Minimum Angle of Resolution (LogMAR))(LogMAR) | Implantation or Explantation Safety Cohort |
|---|---|
| Mean | 0.525 ± 0.084 |
| Bilateral Uncorrected Intermediate Visual Acuity (UCIVA LogMAR)(LogMAR) | Implantation or Explantation Safety Cohort |
|---|---|
| Mean | 0.335 ± 0.151 |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Refocus Group, Inc.