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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens implantation +1.00 diopter (D) postop target | Experimental | Lens implant power calculated for postoperative MRSE target of +1.00 D |
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| Lens implantation -1.00 D postop target | Experimental | Lens implant power calculated for postoperative MRSE target of -1.00 D |
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| Lens implantation 0.00 D postop target | Experimental | Lens implant power calculated for postoperative MRSE target of 0.00 D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens implantation +1.00 D postop target | Device | Lens implantation +1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Doyle Stulting, MD, PhD | Emory Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altos Eye Physicians | Los Altos | California | 94024 | United States | ||
| Maloney Vision Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens Implant Power +1.00 D Target | Lens implant power +1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative +1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Phase 2 medical device study
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| Lens implantation -1.00 D postop target | Device | Lens implantation -1.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction. |
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| Lens implantation 0.00 D postop target | Device | Lens implantation 0.00 D postoperative MRSE target. Light Delivery Device treatment based on postoperative manifest refraction. |
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| 6 months post operative |
| Los Angeles |
| California |
| 90024 |
| United States |
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| Discover Vision Centers | Leawood | Kansas | 66211 | United States |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | United States |
| CODET Vision Institute | Tijuana | Zona Rio | 22320 | Mexico |
| FG001 | Lens Implant Power -1.00 D Target | Lens implant power -1.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative -1.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power. |
| FG002 | Lens Implant Power 0.00 D Target | Lens implant power 0.00 D target: Subjects who require cataract extraction and intraocular lens implantation are implanted with the Light Adjustable Lens with a postoperative 0.00 D MRSE target. At 17 to 21 days, the manifest refraction is measured and the implanted LAL is treated with a targeted dose of light using the Light Delivery Device to produce a modification in the lens curvature, resulting in a predictable change in refractive power. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lens Implant Power +1.00 D Target | The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 diopter |
| BG001 | Lens Implant Power 0.00 D Target | The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 diopter |
| BG002 | Lens Implant Power -1.00 D Target | The eyes would have a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 11.00 diopter |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT | Posted | Number | percentage of eyes | 6 months post-operative |
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| Secondary | 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. | Participants with eyes with UCVA of 20/50 or worse UCVA prior to light treatment | Posted | Number | percentage of eyes | 6 months post operative |
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| Other Pre-specified | 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. | All available eyes at 12 months. The overall number of participants for this outcome measures differs the previously stated overall number of 74 because two subjects were deceased at their 12 month post-operative follow up visit. | Posted | Number | percentage of eyes | 12 months |
|
36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lens Implant Power of +1.00 D Target | Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of +1.00 D | 0 | 25 | 3 | 25 | 18 | 25 |
| EG001 | Lens Implant Power of -1.00 D Target | Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of -1.00 D | 2 | 25 | 2 | 25 | 15 | 25 |
| EG002 | Lens Implant Power of 0.00 D | Eyes with a post-surgical Manifest Refraction Spherical Equivalent (MRSE) target of 0.00 D | 1 | 24 | 1 | 24 | 14 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary Surgical Intervention | Eye disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Optic neuritis | Eye disorders | Systematic Assessment |
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| epiretinal membrane and macular hole | Eye disorders | Systematic Assessment |
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| wet age related macular degeneration | Eye disorders | Systematic Assessment |
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| macular edema secondary to epiretinal membrate | Eye disorders | Systematic Assessment |
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| heart attack with pacemaker implanted | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior Capsular Opacity | Eye disorders | Systematic Assessment |
| ||
| Blepharitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen O'Connell Vice President, Regulator and Clinical Affairs | RxSight, Inc. | 978-207-12415 | moconnell@rxsight.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Units | Counts |
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| Participants |
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