An interventional study of Light Adjustable lens (LAL) and Light Delivery Device (LDD) in Aphakia and Cataract, sponsored by RxSight, Inc.. Completed at 1 site in Mexico. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by RxSight, Inc. · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 21 is below the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →RxSight, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
Percent of Eyes With UCDVA of 20/20 or Better
Time frame: 6 months
| Milestone | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
| Eyes | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Percent of Eyes With UCDVA of 20/20 or Better | 41 |
Collected over Through study completion, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 0/21 (0%) | 0/42 (0%) | 1/42 (2.4%) |
| Event | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Cystoid Macular EdemaEye disorders | 1/42 |
| Age, Continuous(years) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Mean | 68.3 ± 5.3 |
| Sex: Female, Male(Participants) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Female | 12 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Hispanic or Latino | 18 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Mexico | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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RxSight, Inc.