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The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Delivery Device (LDD) | Experimental | Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Delivery Device (LDD) | Device | Study eye will undergo Light delivery Device treatments |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | Post Op Month 3 | |
| Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | Post Op Month 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated) | Number of study eyes experiencing Ocular adverse events (device related and unrelated) | Through study completion, an average of 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States | ||
| Vance Thompson Vision Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Delivery Device (LDD) | Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo 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 | May 23, 2019 |
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All subjects will receive the same treatment
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| Sioux Falls |
| South Dakota |
| 57108 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Delivery Device (LDD) | Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments |
| 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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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | Posted | Mean | Standard Deviation | Diopter (D) | Post Op Month 3 |
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| Primary | Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | Posted | Mean | Standard Deviation | Diopter (D) | Post Op Month 3 |
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| Other Pre-specified | Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated) | Number of study eyes experiencing Ocular adverse events (device related and unrelated) | Safety population | Posted | Number | eyes | Through study completion, an average of 3 months |
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Through study completion, an average of 3 months.
Non-ocular adverse events were not collected. Adverse events were counted by eye.
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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 Delivery Device (LDD) | Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens. Light Delivery Device (LDD): Study eye will undergo Light Delivery Device treatments | 0 | 25 | 0 | 25 | 4 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-clinically significant cystoid macular edema | Eye disorders | Systematic Assessment |
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| Non-clinically significant cystoid macular edema in non-study eye | Eye disorders | Systematic Assessment |
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| Posterior Capsular Opacity (PCO) that requires YAG Capsulotomy treatment | 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 |
| Mar 17, 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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| 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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