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 30 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by RxSight, Inc. · Interventional and Treatment
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 79 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)
Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
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.
Time frame: 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
Time frame: 12 months post op
| Milestone | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Started | 79 |
| Completed | 79 |
| Not completed | 0 |
Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
| Eyes | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better | 21 |
Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment
| Eyes | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| 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 | 91 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 1/79 (1.3%) | 2/79 (2.5%) | 9/79 (11.4%) |
| Event | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Cardiogenic ShockCardiac disorders | 1/79 |
| Blood clots secondary to head trauma from a fallVascular disorders | 1/79 |
| Event | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Epiretinal membraneEye disorders | 3/79 |
| DrusenEye disorders | 2/79 |
| Intraretinal microhemorrhage secondary to diabetes and hypertensionEye disorders | 1/79 |
| Microaneurism, intraretinal hemorrhage dots secondary to history of diabetesEye disorders | 1/79 |
| Corneal epithelium: epithelialized with SPKEye disorders | 1/79 |
| Granular deposits over IOLEye disorders | 1/79 |
| Pigmentary changesEye disorders | 1/79 |
| Optic nerve edema secondary to head traumaNervous system disorders | 1/79 |
| Posterior capsular opacityEye disorders | 1/79 |
| Age, Continuous(years) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Mean | 66.6 ± 7.2 |
| Sex: Female, Male(Participants) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Female | 53 |
| Male | 26 |
| Race/Ethnicity, Customized(Participants) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| White | 59 |
| Black | 0 |
| Other | 0 |
| Not Reported | 20 |
| Region of Enrollment(participants) | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|
| Mexico | 79 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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RxSight, Inc.