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The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.
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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 | Eligible eyes will receive Light adjustable lens with Light delivery Device treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | 3 months post op |
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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): Eligible 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 9, 2019 |
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| 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): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments |
| 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 | Participants |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Eyes | 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 | Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | Posted | Count of Units | Eyes | 3 months post op | Eyes | Eyes |
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Through study completion, an average of 3 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): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments | 0 | 66 | 0 | 111 | 25 | 111 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Capsule Rupture | Eye disorders | Systematic Assessment |
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| BCDVA Drop of 10 letters of more | Eye disorders | Systematic Assessment |
| ||
| Corneal Erosion | Eye disorders | Systematic Assessment |
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| Corneal Guttata | Eye disorders | Systematic Assessment |
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| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
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| Iris Atrophy | Eye disorders | Systematic Assessment |
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| Iritis | Eye disorders | Systematic Assessment |
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| Posterior Capsular Opacity | Eye disorders | Systematic Assessment |
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| Superficial Punctate Keratitis | Eye disorders | Systematic Assessment |
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| Vision changes including night vision changes | 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 |
| Aug 4, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Black |
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| Other |
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