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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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing. | 3 months post op |
| Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better | Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment | 12 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 | Nov 20, 2020 |
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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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| 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 |
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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 | Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing. | Posted | Count of Units | Eyes | 3 months post op | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||
| Primary | Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better | Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment | Posted | Count of Units | Eyes | 12 months post op | Eyes | Eyes |
|
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12 months
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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 | 1 | 79 | 2 | 79 | 9 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
| ||
| Blood clots secondary to head trauma from a fall | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraretinal microhemorrhage secondary to diabetes and hypertension | Eye disorders | Systematic Assessment |
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| Microaneurism, intraretinal hemorrhage dots secondary to history of diabetes | Eye disorders | Systematic Assessment |
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| Corneal epithelium: epithelialized with SPK | Eye disorders | Systematic Assessment |
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| Granular deposits over IOL | Eye disorders | Systematic Assessment |
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| Epiretinal membrane | Eye disorders | Systematic Assessment |
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| Drusen | Eye disorders | Systematic Assessment |
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| Pigmentary changes | Eye disorders | Systematic Assessment |
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| Optic nerve edema secondary to head trauma | Nervous system disorders | Systematic Assessment |
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| Posterior capsular opacity | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials | RxSight, Inc. | 9494215463 | dgoffredo@rxsight.com |
| Dec 12, 2024 |
| 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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| Other |
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| Not Reported |
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| Eyes |
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