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Technology changes.
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The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light adjustable lens (LAL) and Light Delivery Device (LDD) | Experimental |
| |
| SofPort LI61AO IOL | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Device | Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group. | Postop Month 6 |
| Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups | Postop Month 6 |
| Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6 | Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR | 6 months |
| Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups | Postop Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States |
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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): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| FG001 | Tecnis ZCB00 or ZTC150 IOL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-COVID Population |
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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 | Oct 12, 2020 |
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Subjects will be randomized 1:1 to undergo experimental or control treatment.
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Select post operative assessments will be performed on both the experimental and control treatment groups by an examiner who will be masked to the treatment group assignments.
| SofPort LI61AO IOL | Device | Control treatment group will receive SofPort LI61AO IOL |
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| Tecnis ZCB00 or ZTC150 IOL | Device | Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL |
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Tecnis ZCB00/ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL |
| FG002 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| FG003 | SofPort LI61AO IOL | SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL |
| COMPLETED |
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| NOT COMPLETED |
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| Modified Safety Population |
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Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled (Light adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID population and Tecnis ZCB00 or ZTC150 IOL) may have been delayed outside protocol specified windows or missed completely. Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| BG001 | Tecnis ZCB00 or ZTC150 IOL | Tecnis ZCB00/ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL |
| BG002 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| BG003 | SofPort LI61AO IOL | SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL |
| BG004 | Total | Total of all reporting groups |
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of 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 | Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group | Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group. | Posted | Number | Diopters | Postop Month 6 | Primary Eyes | Primary Eyes |
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| Primary | Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group | Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups | Since the sample sizes of each group did not meet the minimum requirements (8 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups. | Posted | Mean | 95% Confidence Interval | LogMAR | Postop Month 6 | Primary Eyes | Primary Eyes |
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| Primary | Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6 | Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR | Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled (Light adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID population and TECNIS ZCB00 or ZTC150 IOL) may have been delayed outside protocol specified windows or missed completely. Since the sample sizes of each group did not meet the minimum requirements (28 eyes per lens group) for statistical power per study protocol, 95% confidence intervals were calculated. | Posted | Number | 95% Confidence Interval | percentage of Primary Eyes | 6 months | Primary Eyes | Primary Eyes |
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| Primary | Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group | Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups | Since the sample sizes of each group did not meet the minimum requirements (42 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups. | Posted | Mean | 95% Confidence Interval | LogMAR | Postop Month 6 | Primary Eyes | Primary Eyes |
|
6 months
Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely (i.e., "Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population", "Tecnis ZCB00 or ZTC150 IOL"). Per the protocol, these subjects will be excluded from the Full Analysis Set populations.
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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) - Pre-COVID Population | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments | 0 | 10 | 1 | 10 | 9 | 10 |
| EG001 | Tecnis ZCB00 or ZTC150 IOL | Tecnis ZCB00 or ZTC150 IOL: Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL | 0 | 7 | 1 | 7 | 2 | 7 |
| EG002 | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population | Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments | 0 | 7 | 1 | 7 | 4 | 7 |
| EG003 | SofPort LI61AO IOL | SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL | 0 | 10 | 1 | 10 | 1 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gall bladder removal | Hepatobiliary disorders | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | Systematic Assessment |
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| Laparoscopic cholecystectomy for gall stones | Hepatobiliary disorders | Systematic Assessment |
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| Internal and external hemorrhoids requiring hospitalization | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary and Fellow Eye, BCDVA letter drop 10 letters or worse compared to week 3 | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Posterior capsular opacity requiring YAG | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Non-clinically significant cystoid macular edema | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Punctate Epithelial Erosion causing watery and uncomfortable eye | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Subjective symptom of blurry vision, red in lights and starbursts | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Subjective symptom of much less crisp vision | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Glare or halos or double/multiple images | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Drusen | Eye disorders | Systematic Assessment |
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| Primary and Fellow Eye, Cellulitis, hordeolum | Eye disorders | Systematic Assessment |
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Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely. Per the protocol, these subjects will be excluded from the Full Analysis Set populations. Based on the sample size calculations, at least 42 subjects per lens group with available monocular photopic BCDVA and DCIVA for the primary eyes at Postop Month 6 were needed; however, the sample size was too small to analyze these endpoints.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Ha, VP Clinical Affairs | RxSight | 949-521-7870 | jha@rxsight.com |
| Jan 10, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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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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| Black/African American |
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| Asian |
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| American Indian/Alaska Native |
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| Native Hawaiian/Pacific Islander |
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| Other |
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| Primary Eyes |
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| OG003 | SofPort LI61AO IOL | SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL |
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| Units | Counts |
|---|---|
| Participants |
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| Primary Eyes |
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| OG003 | SofPort LI61AO IOL | SofPort LI61AO IOL: Control treatment group will receive SofPort LI61AO IOL |
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