An interventional study of Lens implantation +1.00 D postop target and Lens implantation -1.00 D postop target in Cataracts, sponsored by Calhoun Vision, Inc.. Completed at 6 sites in 2 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Calhoun Vision, Inc. · Not applicable, Interventional, and Treatment
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the Calhoun Vision Light Adjustable intraocular lens (LAL) and Light Delivery Device (LDD) in treating postoperative residual refractive error by providing a stable, targeted refractive adjustment of the LAL power and lock-in treatments with the LDD.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 74 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Calhoun Vision, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lens implant power calculated for postoperative MRSE target of +1.00 D
Device: Lens implantation +1.00 D postop target
Lens implant power calculated for postoperative MRSE target of -1.00 D
Device: Lens implantation -1.00 D postop target
Lens implant power calculated for postoperative MRSE target of 0.00 D
Device: Lens implantation 0.00 D postop target
Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Also known as: Light Delivery Device
Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Also known as: Light Delivery Device
Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction.
Also known as: Light Delivery Device
Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time frame: 6 months post-operative
Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)
Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time frame: 6 months post operative
Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better
Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.
Time frame: 12 months
| Milestone | Lens Implant Power +1.00 D Target | Lens Implant Power -1.00 D Target | Lens Implant Power 0.00 D Target |
|---|---|---|---|
| Started | 25 | 25 | 24 |
| Completed | 23 | 23 | 23 |
| Not completed | 2 | 2 | 1 |
| Withdrew: Death | 1 | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 |
Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.
| percentage of eyes | Lens Implant Power -1.00 D Target | Lens Implant Power +1.00 D Target | Lens Implant Power 0.00 D Target |
|---|---|---|---|
| Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target | 78.3 | 80.0 | 79.2 |
Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.
| percentage of eyes | Lens Implant Power -1.00 D Target | Lens Implant Power of +1.00 D | Lens Implant Power of 0.0 D Target |
|---|---|---|---|
| Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA) | 77.8 | 100 | 0 |
Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.
| percentage of eyes | Lens Implant Power With -1.00 D Target | Lens Implant Power With 0.00 D Target | Lens Implant Power With +1.00 D Target |
|---|---|---|---|
| Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better | 100 | 100 | 100 |
Collected over 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lens Implant Power of +1.00 D Target | 0/25 (0%) | 3/25 (12%) | 18/25 (72%) |
| Lens Implant Power of -1.00 D Target | 2/25 (8%) | 2/25 (8%) | 15/25 (60%) |
| Lens Implant Power of 0.00 D | 1/24 (4.2%) | 1/24 (4.2%) | 14/24 (58.3%) |
| Event | Lens Implant Power of +1.00 D Target | Lens Implant Power of -1.00 D Target | Lens Implant Power of 0.00 D |
|---|---|---|---|
| Secondary Surgical InterventionEye disorders | 1/25 | 1/25 | 1/24 |
| epiretinal membrane and macular holeEye disorders | 0/25 | 0/25 | 1/24 |
| heart attack with pacemaker implantedCardiac disorders | 0/25 | 0/25 | 1/24 |
| StrokeNervous system disorders | 0/25 | 1/25 | 0/24 |
| Optic neuritisEye disorders | 1/25 | 0/25 | 0/24 |
| wet age related macular degenerationEye disorders | 0/25 | 1/25 | 0/24 |
| macular edema secondary to epiretinal membrateEye disorders | 1/25 | 0/25 | 0/24 |
| Event | Lens Implant Power of +1.00 D Target | Lens Implant Power of -1.00 D Target | Lens Implant Power of 0.00 D |
|---|---|---|---|
| Posterior Capsular OpacityEye disorders | 17/25 | 15/25 | 13/24 |
| BlepharitisEye disorders | 1/25 | 1/25 | 2/24 |
| Age, Continuous(years) | Lens Implant Power +1.00 D Target | Lens Implant Power 0.00 D Target | Lens Implant Power -1.00 D Target | Total |
|---|---|---|---|---|
| Mean | 66.3 ± 9.3 | 65.6 ± 7.3 | 65.9 ± 9.2 | 66.1 ± 8.6 |
| Sex: Female, Male(Participants) | Lens Implant Power +1.00 D Target | Lens Implant Power 0.00 D Target | Lens Implant Power -1.00 D Target | Total |
|---|---|---|---|---|
| Female | 15 | 17 | 12 | 44 |
| Male | 10 | 7 | 13 | 30 |
| Race (NIH/OMB)(Participants) | Lens Implant Power +1.00 D Target | Lens Implant Power 0.00 D Target | Lens Implant Power -1.00 D Target | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 21 | 15 | 19 | 55 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 8 | 6 | 17 |
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Calhoun Vision, Inc.