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The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD) | Device | Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eyes With UCDVA of 20/20 or Better | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CODET Vision Institute | Tijuana | Mexico |
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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): Primary and Fellow eyes 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 | Apr 27, 2018 |
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All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.
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| COMPLETED |
|
| 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): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments |
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | 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 | Percent of Eyes With UCDVA of 20/20 or Better | Posted | Count of Units | Eyes | 6 months | Eyes | Eyes |
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Through study completion, an average of 6 months
The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.
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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): Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments | 0 | 21 | 0 | 42 | 1 | 42 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid Macular Edema | Eye disorders | Systematic Assessment | Corneal Edema (corneal swelling (stromal or epithelial) resulting in BCDVA ≤ 20/40 after Postop Week 3 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Ha, Senior Director of Clinical Research | RxSight | 949-521-7870 | jha@rxsight.com |
| Mar 29, 2021 |
| 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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| Unknown or Not Reported |
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