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The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAL | Experimental | LAL implanted |
|
| Monofocal control | Active Comparator | Monofocal control IOL implanted |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAL (Light Adjustable Lens) and Light Deliver Device (LDD) | Device | LAL implanted and adjusted with LDD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction in Manifest Cylinder | Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. | 6 months |
| Percent Absolute Reduction in MRSE | Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. | 6 months |
| Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop | Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity 20/20 or Better | Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States | ||
| Jules Stein Eye Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | LAL Implant | LAL implanted LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD |
| FG001 | Monofocal Control | Monofocal control IOL implanted Monofocal control IOL: Commercially available monofocal intraocular lens (IOL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Phase 3 medical device study
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| Monofocal control IOL | Device | Commercially available monofocal intraocular lens (IOL) |
|
| Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) |
Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately. |
| 6 months |
| Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) | Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group. | 6 months |
| Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively | For eyes with <0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. | 6 months |
| Mean BSCVA | Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta). | 6 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Newsom Eye | Sebring | Florida | 33870 | United States |
| Arbor Centers for Eye Care | Orland Park | Illinois | 60467 | United States |
| Eye Surgeons of Indiana | Indianapolis | Indiana | 46256 | United States |
| Jones Eye Clinic | Sioux City | Iowa | 51104 | United States |
| Discover Vision & Laser Center | Leawood | Kansas | 66211 | United States |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
| Ophthalmology Consultants, Ltd. | St Louis | Missouri | 63131 | United States |
| EyeSight Ophthalmic Services, PA | Somersworth | New Hampshire | 03878 | United States |
| Carolina Vision Center | Fayetteville | North Carolina | 28304 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57105 | United States |
| Eye Consultants of Texas | Grapevine | Texas | 76051 | United States |
| Focal Point Vision | San Antonio | Texas | 78229 | United States |
| Hoopes Vision | Draper | Utah | 84020 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LAL Implant | LAL implanted LAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD |
| BG001 | Monofocal Control | Monofocal control IOL implanted Monofocal control IOL: Commercially available monofocal intraocular lens (IOL) |
| BG002 | 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Right Eye | Number | Eyes |
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| Left Eye | Number | Eyes |
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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 | Percent Reduction in Manifest Cylinder | Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. | ITT. Only eyes that had cylinder in the range of treatment (>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study. | Posted | Mean | 95% Confidence Interval | percent reduction in manifest cylinder | 6 months |
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| Primary | Percent Absolute Reduction in MRSE | Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. | ITT. Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study. | Posted | Mean | 95% Confidence Interval | percentage of reduction in MRSE | 6 months |
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| Primary | Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop | Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined. | ITT: The overall number of participants analyzed differs from the other outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure. | Posted | Number | 95% Confidence Interval | percentage of eyes | 6 months |
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| Secondary | Uncorrected Visual Acuity 20/20 or Better | Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively. | ITT | Posted | Number | percentage of eyes | 6 months |
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| Secondary | Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D) | Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately. | Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment | Posted | Mean | Standard Deviation | percent reduction in cylinder | 6 months |
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| Secondary | Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D) | Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group. | Participants with eyes in ITT with >1.25 D of cylinder prior to light treatment | Posted | Mean | Standard Deviation | percent reduction in cylinder | 6 months |
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| Secondary | Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively | For eyes with <0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. | Participants with eyes in ITT with <0.75 D of cylinder prior to light treatment | Posted | Mean | Standard Deviation | percent absolute reduction in MRSE | 6 months |
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| Secondary | Mean BSCVA | Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta). | ITT population best case cohort with no macular problems | Posted | Mean | Standard Deviation | LogMAR | 6 months |
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12 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 | Light Adjustable Lens | Randomized to have the Light Adjustable Lens implanted | 1 | 403 | 42 | 403 | 292 | 403 |
| EG001 | Monofocal Control IOL | Randomized to have the Monofocal control IOL implanted | 4 | 197 | 10 | 197 | 125 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpetic Keratouveitis | Eye disorders | Systematic Assessment |
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| Persistent Induced Tritan Color Anomaly | Eye disorders | Systematic Assessment |
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| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
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| Endophthalmitis | Eye disorders | Systematic Assessment |
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| Horseshoe retinal tear with vitreous hemorrhage | Eye disorders | Systematic Assessment |
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| Hypopyon | Eye disorders | Systematic Assessment |
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| Surgical complication | Eye disorders | Systematic Assessment | Surgical complication including anterior segment bleeding, vitreous loss, and posterior capsule and zonular rupture |
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| Anxiety | Nervous system disorders | Systematic Assessment |
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| Blood clots due to lymphoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Broken blood vessel in brain | Vascular disorders | Systematic Assessment |
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| Broken wrist | General disorders | Systematic Assessment |
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| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest pain with pacemaker | Cardiac disorders | Systematic Assessment |
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| Heart palpitations | Cardiac disorders | Systematic Assessment |
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| Heart surgery | Cardiac disorders | Systematic Assessment |
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| Hospitalization due to cellulitis | Infections and infestations | Systematic Assessment |
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| Hospitalization due to concussion with subdural hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hospitalization due to emphysema/COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hospitalization due to infection after knee surgery | Infections and infestations | Systematic Assessment |
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| Hospitalization due to syncope | General disorders | Systematic Assessment |
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| Hospitalization for colitis | Gastrointestinal disorders | Systematic Assessment |
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| Hospitalization due to low blood pressure and syncope | General disorders | Systematic Assessment |
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| Hospitalization due to dizziness | General disorders | Systematic Assessment |
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| Kidney disease | Renal and urinary disorders | Systematic Assessment |
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| Liver cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Malignant neuroendocrine tumors | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Transient ischemic attack | Vascular disorders | Systematic Assessment |
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| Triple bypass surgery | Cardiac disorders | Systematic Assessment |
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| Secondary surgical intervention | Eye disorders | Systematic Assessment |
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| Phytotoxic retinal damage causing temporary loss of BSCVA | Eye disorders | Systematic Assessment |
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| Persistent induced erythropsia | Eye disorders | Systematic Assessment |
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| Persistent unanticipated increase refractive error | Eye disorders | Systematic Assessment |
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| Intraoperative capsular tear | Eye disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cells | Eye disorders | Systematic Assessment |
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| Anterior chamber flare | Eye disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Corneal edema central | Eye disorders | Systematic Assessment |
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| corneal edema wound | Eye disorders | Systematic Assessment |
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| Posterior capsular opacity | Eye disorders | Systematic Assessment |
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| Raised IOP not requiring treatment | Eye disorders | Systematic Assessment |
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| Raised IOP requiring treatment | Eye disorders | Systematic Assessment |
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| Superficial punctate keratitis | 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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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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