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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 RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Experimental | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. |
|
| Control IOL | Active Comparator | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD) | Device | Primary eye will receive Light adjustable lens with Light delivery Device treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 | |
| Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 | |
| One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5% | Postop Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) | Postop Month 6 | |
| Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination | Postop Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discover Vision Centers | Leawood | Kansas | 66211 | United States | ||
| Cleveland Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments |
| 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 | Jul 3, 2019 |
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All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.
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Select post operative assessments will be performed on both the experimental and control eye by an examiner who will be masked to the eye assignments.
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| Control IOL | Device | Fellow eye will receive control IOL |
|
| Brecksville |
| Ohio |
| 44141 |
| United States |
| Vance Thompson Vision Clinic | Sioux Falls | South Dakota | 57108 | United States |
| Slade & Baker Vision | Houston | Texas | 77027 | United States |
| Focal Point Vision | San Antonio | Texas | 78229 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| FG001 | Control IOL | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive 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) | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments |
| BG001 | Control IOL | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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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 | Eyes |
| ||||||||||||||
| Sex: Female, Male | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Race (NIH/OMB) | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Region of Enrollment | Number | Eyes | Eyes |
| |||||||||||||||
| Eye | Count of Units | Eyes | 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 | Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | Posted | Mean | Standard Deviation | Diopter | Postop Month 6 | Eyes | Eyes |
|
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| ||||||||||||||||||||||||||||||
| Primary | Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | Posted | Mean | Standard Deviation | Diopter | Postop Month 6 | Eyes | Eyes |
|
| |||||||||||||||||||||||||||||||
| Primary | One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5% | Posted | Number | 95% Confidence Interval | percent of eyes w. BCDVA 20/40 or better | Postop Month 6 | Eyes | Eyes |
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| Secondary | Uncorrected Distance Visual Acuity (UCDVA) | Posted | Mean | Standard Deviation | logMAR | Postop Month 6 | Eyes | Eyes |
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| Secondary | Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination | Posted | Mean | Standard Deviation | mean logMAR UCDVA | Postop Month 6 | Eyes | Eyes |
|
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Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
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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) | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments | 0 | 105 | 1 | 105 | 48 | 105 |
| EG001 | Control IOL | A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL. Control IOL: Fellow eye will receive control IOL | 0 | 105 | 0 | 105 | 38 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically significant Cystoid Macular Edema | Eye disorders | Systematic Assessment |
| ||
| Secondary Surgical Intervention (excluding Posterior Capsulotomy) | Eye disorders | Systematic Assessment | Iris Prolapse secondary to fall requiring Iris Repositioning + Suture |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber Inflammation | Eye disorders | Systematic Assessment |
| ||
| Corneal Edema | Eye disorders | Systematic Assessment |
| ||
| Loss of BCDVA of >/= 10 letters (when compared to Preoperative or Postop Week 3 BCDVA) | Eye disorders | Systematic Assessment |
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| Removal of retained Cortex | Eye disorders | Systematic Assessment |
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| Conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Conjunctival hyperemia/edema | Eye disorders | Systematic Assessment |
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| Corneal SPK | Eye disorders | Systematic Assessment |
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| Double vision | Eye disorders | Systematic Assessment |
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| Epiretinal membrane | Eye disorders | Systematic Assessment |
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| Epithelial basement membrane dystrophy appearance | Eye disorders | Systematic Assessment |
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| Epithelial defect | Eye disorders | Systematic Assessment |
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| Glare at night | Eye disorders | Systematic Assessment |
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| Iris atrophy/Medication deposits | Eye disorders | Systematic Assessment |
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| Iris prolapse | Eye disorders | Systematic Assessment |
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| Light sensitivity | Eye disorders | Systematic Assessment |
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| Non-clinically significant cystoid macular edema | Eye disorders | Systematic Assessment |
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| Ocular discomfort | Eye disorders | Systematic Assessment |
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| Posterior vitreous detachment | Eye disorders | Systematic Assessment |
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| Retained cortex | Eye disorders | Systematic Assessment |
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| Vision doesn't fuse together for distance well | Eye disorders | Systematic Assessment |
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| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
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| Vitreous in anterior chamber | Eye disorders | Systematic Assessment |
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| YAG performed to treat capsular phemosis | Eye disorders | Systematic Assessment |
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| YAG performed to treat capsular striae | Eye disorders | Systematic Assessment |
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| YAG performed to treat posterior capsular opacity | Eye disorders | Systematic Assessment |
| ||
| YAG performed to treat vitreous strand | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Ha, Senior Director of Clinical Research | RxSight | 949-521-7870 | jha@rxsight.com |
| Oct 21, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| 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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| OS Eye |
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| Eyes |
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| Eyes |
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| Eyes |
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| Eyes |
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