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The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Experimental |
| |
| Control IOL | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD) | Device | Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 | |
| Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Endothelial Cell Density Loss | The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05. | Postop Month 6 |
| Rate of Retinal Findings |
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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 | ||
| Reeve Woods Eye Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41664266 | Derived | Holladay JT, Haller M. Light-adjustable lens results of spherical equivalent and astigmatism correction from the U.S. Food and Drug Administration postapproval study. J Cataract Refract Surg. 2026 Jul 1;52(7):666-669. doi: 10.1097/j.jcrs.0000000000001906. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| FG001 | Control IOL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2023 |
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Subjects will be randomized 2:1 to undergo experimental or control treatment.
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| Control IOL | Device | Control treatment group will receive a Control IOL |
|
Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only. |
| Postop Month 6 |
| Chico |
| California |
| 95926 |
| United States |
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| Newsom Eye | Sebring | Florida | 33870 | United States |
| Vance Thompson Vision | Alexandria | Minnesota | 56308 | United States |
| Vance Thompson Vision | Omaha | Nebraska | 68137 | United States |
| Center for Sight | Las Vegas | Nevada | 89145 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Vance Thompson Vision Clinic | Sioux Falls | South Dakota | 57108 | United States |
| Key-Whitman Eye Center | Dallas | Texas | 75235 | United States |
| Slade & Baker Vision | Houston | Texas | 77027 | United States |
| Texas Eye Research Center | Hurst | Texas | 76054 | United States |
| Focal Point Vision | San Antonio | Texas | 78229 | United States |
Control IOL: Control treatment group will receive a Control IOL |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| BG001 | Control IOL | Control IOL: Control treatment group will receive a Control 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | Posted | Mean | Standard Deviation | Diopters | Postop Month 6 |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | Posted | Mean | Standard Deviation | Diopters | Postop Month 6 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Rate of Endothelial Cell Density Loss | The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05. | Posted | Median | 95% Confidence Interval | percentage Endothelial Cell Change | Postop Month 6 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Rate of Retinal Findings | Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only. | Posted | Count of Participants | Participants | Postop Month 6 |
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| Post-Hoc | Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group | Success defined as UCDVA 20/20 or better, failure defined as UCDVA worse than 20/20. Odds defined as number of successes divided by number of failures. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||
| Post-Hoc | Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group | Posted | Count of Participants | Participants | 6 months |
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| ||||||||||||||||||||||||||||||||
| Post-Hoc | Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group | Posted | Count of Participants | Participants | 6 months |
|
|
6 months
Non-serious, ocular AEs are being reported for study eyes only.
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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 (LAL) and Light Delivery Device (LDD) | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments | 0 | 335 | 7 | 335 | 71 | 335 |
| EG001 | Control IOL | Control IOL: Control treatment group will receive a Control IOL | 0 | 165 | 2 | 165 | 26 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary Surgical Intervention: Intraocular Lens Exchange | Surgical and medical procedures | Systematic Assessment |
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| Secondary Surgical Intervention: Iris Repositioning following prolapse | Surgical and medical procedures | Systematic Assessment |
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| Secondary Surgical Intervention: Study Eye, Selective Laser Trabeculoplasty | Surgical and medical procedures | Systematic Assessment |
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| Secondary Surgical Intervention: Non-Study Eye Intraocular Lens Exchange | Surgical and medical procedures | Systematic Assessment |
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| Non-Study Eye, Full Thickness Macular Hole | Eye disorders | Systematic Assessment |
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| Secondary Surgical Intervention: Non-Study Eye, Macular Hole Repair | Surgical and medical procedures | Systematic Assessment |
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| Inpatient hospitalization following Hip Replacement Surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Inpatient hospitalization for Ventral Hernia Repair Surgery | Surgical and medical procedures | Systematic Assessment |
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| Inpatient hospitalization due to Pneumonia | Infections and infestations | Systematic Assessment |
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| Inpatient hospitalization due to Salmonella Infection | Infections and infestations | Systematic Assessment |
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| Inpatient hospitalization due to Obstruction of Gallbladder | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Conjunctivitis | Eye disorders | Systematic Assessment |
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| Amaurosis Fugax | Eye disorders | Systematic Assessment |
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| Anterior Chamber Inflammation | Eye disorders | Systematic Assessment |
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| Blepharoplasty | Surgical and medical procedures | Systematic Assessment |
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| Blurry Vision | Eye disorders | Systematic Assessment |
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| Clinically significant cystoid macular edema | Eye disorders | Systematic Assessment |
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| Conjunctival Cyst | Eye disorders | Systematic Assessment |
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| Corneal Abrasion | Eye disorders | Systematic Assessment |
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| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
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| De-centered optic | Eye disorders | Systematic Assessment |
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| Dot Hemorrhage | Eye disorders | Systematic Assessment |
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| Epithelial Defect | Eye disorders | Systematic Assessment |
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| Hypertensive Retinopathy | Eye disorders | Systematic Assessment |
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| Iritis | Eye disorders | Systematic Assessment |
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| Keratoconjunctivitis Sicca, not specified as Sjogrens | Eye disorders | Systematic Assessment |
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| Corneal Erosion | Eye disorders | Systematic Assessment |
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| Corneal Edema | Eye disorders | Systematic Assessment |
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| Conjunctivochalasis | Eye disorders | Systematic Assessment |
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| Conjunctivitis Medicamentosa | Eye disorders | Systematic Assessment |
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| Conjunctival Hyperemia | Eye disorders | Systematic Assessment |
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| Visual Symptoms due to Concussion | Eye disorders | Systematic Assessment |
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| Dot Hemorrhages and Microaneurysms | Eye disorders | Systematic Assessment |
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| Dry Eye | Eye disorders | Systematic Assessment |
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| Dry Eye Syndrome | Eye disorders | Systematic Assessment |
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| Epiretinal Membrane | Eye disorders | Systematic Assessment |
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| Epithelial Basement Membrane Dystrophy | Eye disorders | Systematic Assessment |
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| Erythropsia score 2 (red) any time after Week 3 or Erythropsia score 1 (pink) or 2 (red) at Month 6 | Eye disorders | Systematic Assessment |
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| Floaters | Eye disorders | Systematic Assessment |
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| Headache | Eye disorders | Systematic Assessment |
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| Hordeolum | Eye disorders | Systematic Assessment |
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| Light Treatment Sensitivity | Eye disorders | Systematic Assessment |
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| Loss of BCDVA of >= 10 letters (when compared to Preop and/or Postop Week 3 BCDVA) | Eye disorders | Systematic Assessment |
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| Meibomian Gland Dysfunction | Eye disorders | Systematic Assessment |
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| Ocular Allergies | Eye disorders | Systematic Assessment |
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| Ocular Hypertension | Eye disorders | Systematic Assessment |
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| Posterior Capsular tear | Eye disorders | Systematic Assessment |
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| Posterior Vitreous Detachment | Eye disorders | Systematic Assessment |
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| Raised IOP | Eye disorders | Systematic Assessment |
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| Raised IOP >=10 mmHg above preop & >=25 mmHg (if present > Week 1), unrelated to mech. pupil. block | Eye disorders | Systematic Assessment |
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| Rebound Iritis | Eye disorders | Systematic Assessment |
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| Retinal Hole | Eye disorders | Systematic Assessment |
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| Retinal Microaneurysm | Eye disorders | Systematic Assessment |
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| Subconjunctival Abrasion with Hemorrhage | Eye disorders | Systematic Assessment |
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| Superficial Punctate Keratitis | Eye disorders | Systematic Assessment |
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| Uveitis | Eye disorders | Systematic Assessment |
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| Wound leak | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Trials | RxSight, Inc. | 9494215463 | 300 | dgoffredo@rxsight.com |
| Feb 25, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| Caucasian |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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