An interventional study of Light Delivery Device (LDD) in Aphakia and Cataract, sponsored by RxSight, Inc.. Completed at 2 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by RxSight, Inc. · Not applicable, Interventional, and Treatment
The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 25 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.
Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.
Device: Light Delivery Device (LDD)
Study eye will undergo Light delivery Device treatments
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time frame: Post Op Month 3
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time frame: Post Op Month 3
Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated)
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
Time frame: Through study completion, an average of 3 months
| Milestone | Light Delivery Device (LDD) |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
| Diopter (D) | Light Delivery Device (LDD) |
|---|---|
| Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | -0.14 ± 0.21 |
| Diopter (D) | Light Delivery Device (LDD) |
|---|---|
| Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups | 0.36 ± 0.21 |
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
| eyes | Light Delivery Device (LDD) |
|---|---|
| Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated) | 4 |
Collected over Through study completion, an average of 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light Delivery Device (LDD) | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Event | Light Delivery Device (LDD) |
|---|---|
| Posterior Capsular Opacity (PCO) that requires YAG Capsulotomy treatmentEye disorders | 3/25 |
| Non-clinically significant cystoid macular edemaEye disorders | 1/25 |
| Non-clinically significant cystoid macular edema in non-study eyeEye disorders | 1/25 |
| Age, Continuous(years) | Light Delivery Device (LDD) |
|---|---|
| Mean | 67.2 ± 5.4 |
| Sex: Female, Male(Participants) | Light Delivery Device (LDD) |
|---|---|
| Female | 11 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Light Delivery Device (LDD) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | NA |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Light Delivery Device (LDD) |
|---|---|
| United States | 25 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2019 to primary completion in Mar 2020, 8 months.
Results were first posted in Jun 2021, 1 year 3 months after primary completion.
Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 8 months is below that.
Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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RxSight, Inc.