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For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RxSight RxLAL IOL | Other | Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RxSight RxLAL | Device | The patients will be assessed for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better | at 6 months postop |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety: ISO 11979-7 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 6 months |
| Number of Eyes That Received Secondary Surgical Interventions (SSIs) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burkhard Dick, MD | University Eye Clinic- Bochum, Germany | Principal Investigator |
| Fritz Hengerer, MD | University Eye Clinic- Heidelberg, Germany | Principal Investigator |
| Sathish Srinivasan, MD | Ayrshire Eye Clinic and Laser Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Eye Clinic | Bochum | Germany | ||||
| University Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | RxSight RxLAL IOL | Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RxSight RxLAL IOL | Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better | A modified Effectiveness (m-Effectiveness) population was used for all effectiveness analyses which includes all observed data without treatment related protocol deviations. | Posted | Count of Units | Eyes | at 6 months postop | Eyes | Eyes |
|
|
Through study completion, an average of 6 months
Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
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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 | RxSight RxLAL IOL | Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL) RxSight RxLAL: The patients will be assessed for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOL Explant | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of BSCVA of ≥ 10 letters due to dry Eye | Eye disorders | Systematic Assessment | Compared to 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 |
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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: CSP-025-05 rev DE protocol and SAP 05-16-2019_Redacted | May 16, 2019 | Mar 18, 2021 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: CSP-025 rev 5 UK protocol and SAP 05-16-2019_Redacted | May 16, 2019 | Mar 29, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
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Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study. |
| Through study completion, an average of 6 months |
| Heidelberg |
| Germany |
| Ayrshire Eye Clinic and Laser Center | Ayr | Scotland | United Kingdom |
| Eyes |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race/Ethnicity, Customized | Number | participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
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| Primary Eyes Enrolled | Subjects dominant eyes were assigned to the Primary Eye Enrolled group. | "Primary eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories | Count of Units | Eyes | Eyes |
|
|
| Fellow Eyes Enrolled | Subjects non- dominant eyes were assigned to the Fellow Eye Enrolled group. | "Fellow eyes enrolled" represent a count of units distributed across mutually exclusive and exhaustive categories | Count of Units | Eyes | Eyes |
|
|
| Participants |
|
| Eyes |
|
|
| Other Pre-specified | Safety: ISO 11979-7 Ocular Adverse Events (Device Related and Unrelated) | Number of study eyes experiencing Ocular adverse events (device related and unrelated) | Safety population | Posted | Count of Units | Eyes | Through study completion, an average of 6 months | Eyes | Eyes |
|
|
|
| Other Pre-specified | Number of Eyes That Received Secondary Surgical Interventions (SSIs) | Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study. | Posted | Count of Units | Eyes | Through study completion, an average of 6 months | Eyes | Eyes |
|
|
|
| 0 |
| 51 |
| 2 |
| 101 |
| 28 |
| 101 |
| Gastritis with diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| Clinically significant cystoid macular edema | Eye disorders | Systematic Assessment |
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| Corneal 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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| Blurred vision right eye | Eye disorders | Systematic Assessment |
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| Conjunctivitis | Eye disorders | Systematic Assessment |
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| Cornea Epithelialized with SPK | Eye disorders | Systematic Assessment |
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| Diabetic macular edema | Eye disorders | Systematic Assessment |
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| Increased protein distribution after lock-in procedure | Eye disorders | Systematic Assessment |
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| Giant cells on anterior surface of IOL | Eye disorders | Systematic Assessment |
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| Non-clinically significant cystoid macular edema | Eye disorders | Systematic Assessment |
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| Posterior Capsular Opacity | Eye disorders | Systematic Assessment |
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| Loss of BCDVA due to Posterior Capsular Opacity | Eye disorders | Systematic Assessment | Compared to postop week 3 |
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| Loss of BCDVA due to lens aberrations | Eye disorders | Systematic Assessment | Compared to postop week 3 |
|
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