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RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
NA trial testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in Aphakia in 500 participants. Completed in 16 December 2024.
| Lead sponsor | RxSight, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 3 December 2021 |
| Primary completion | 11 September 2024 |
| Estimated completion | 16 December 2024 |
| Sites | 14 locations across United States |
RxSight, Inc.
Adults 40 to 80, any sex, with Aphakia or Cataract. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 0.210 | ± 0.213 |
| Control IOL | 0.345 | ± 0.265 |
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 0.262 | ± 0.275 |
| Control IOL | 0.820 | ± 0.554 |
The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 5.1 | 3.8 – 7.0 |
| Control IOL | 4.9 | 3.0 – 6.5 |
Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 0 |
Success defined as UCDVA 20/20 or better, failure defined as UCDVA worse than 20/20. Odds defined as number of successes divided by number of failures.
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 274 | |
| Control IOL | 83 | |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 58 | |
| Control IOL | 81 |
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 307 | |
| Control IOL | 61 | |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 25 | |
| Control IOL | 103 |
| Group | Value | 95% CI |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 291 | |
| Control IOL | 54 | |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | 41 | |
| Control IOL | 110 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Light Adjustable Lens (LAL… | Control IOL |
|---|---|---|---|
| Secondary Surgical Intervention: Intraocular Lens Exchange | Surgical and medical procedures | — | — |
| Secondary Surgical Intervention: Iris Repositioning following prolapse | Surgical and medical procedures | — | — |
| Secondary Surgical Intervention: Study Eye, Selective Laser Trabeculoplasty | Surgical and medical procedures | — | — |
| Secondary Surgical Intervention: Non-Study Eye Intraocular Lens Exchange | Surgical and medical procedures | — | — |
| Non-Study Eye, Full Thickness Macular Hole | Eye disorders | — | — |
| Secondary Surgical Intervention: Non-Study Eye, Macular Hole Repair | Surgical and medical procedures | — | — |
| Inpatient hospitalization following Hip Replacement Surgery | Injury, poisoning and procedural complications | — | — |
| Inpatient hospitalization for Ventral Hernia Repair Surgery | Surgical and medical procedures | — | — |
| Inpatient hospitalization due to Pneumonia | Infections and infestations | — | — |
| Inpatient hospitalization due to Salmonella Infection | Infections and infestations | — | — |
| Inpatient hospitalization due to Obstruction of Gallbladder | Surgical and medical procedures | — | — |
| Reaction | System | Light Adjustable Lens (LAL… | Control IOL |
|---|---|---|---|
| Superficial Punctate Keratitis | Eye disorders | — | — |
| Raised IOP | Eye disorders | — | — |
| Dry Eye Syndrome | Eye disorders | — | — |
| Anterior Chamber Inflammation | Eye disorders | — | — |
| Clinically significant cystoid macular edema | Eye disorders | — | — |
| Corneal Abrasion | Eye disorders | — | — |
| Loss of BCDVA of >= 10 letters (when compared to Preop and/or Postop Week 3 BCDVA) | Eye disorders | — | — |
| Raised IOP >=10 mmHg above preop & >=25 mmHg (if present > Week 1), unrelated to mech. pupil. block | Eye disorders | — | — |
| Hypertensive Retinopathy | Eye disorders | — | — |
| Iritis | Eye disorders | — | — |
| Keratoconjunctivitis Sicca, not specified as Sjogrens | Eye disorders | — | — |
| Corneal Edema | Eye disorders | — | — |
| Floaters | Eye disorders | — | — |
| Ocular Allergies | Eye disorders | — | — |
| Posterior Vitreous Detachment | Eye disorders | — | — |
| Allergic Conjunctivitis | Eye disorders | — | — |
| Amaurosis Fugax | Eye disorders | — | — |
| Blepharoplasty | Surgical and medical procedures | — | — |
| Blurry Vision | Eye disorders | — | — |
| Conjunctival Cyst | Eye disorders | — | — |
| Cystoid Macular Edema | Eye disorders | — | — |
| De-centered optic | Eye disorders | — | — |
| Dot Hemorrhage | Eye disorders | — | — |
| Epithelial Defect | Eye disorders | — | — |
| Corneal Erosion | Eye disorders | — | — |
| Conjunctivochalasis | Eye disorders | — | — |
| Conjunctivitis Medicamentosa | Eye disorders | — | — |
| Conjunctival Hyperemia | Eye disorders | — | — |
| Visual Symptoms due to Concussion | Eye disorders | — | — |
| Dot Hemorrhages and Microaneurysms | Eye disorders | — | — |
| Dry Eye | Eye disorders | — | — |
| Epiretinal Membrane | Eye disorders | — | — |
| Epithelial Basement Membrane Dystrophy | Eye disorders | — | — |
| Erythropsia score 2 (red) any time after Week 3 or Erythropsia score 1 (pink) or 2 (red) at Month 6 | Eye disorders | — | — |
| Headache | Eye disorders | — | — |
| Hordeolum | Eye disorders | — | — |
| Light Treatment Sensitivity | Eye disorders | — | — |
| Meibomian Gland Dysfunction | Eye disorders | — | — |
| Ocular Hypertension | Eye disorders | — | — |
| Posterior Capsular tear | Eye disorders | — | — |
Most-reported serious reactions: Secondary Surgical Intervention: Intraocular Lens Exchange, Secondary Surgical Intervention: Iris Repositioning following prolapse, Secondary Surgical Intervention: Study Eye, Selective Laser Trabeculoplasty, Secondary Surgical Intervention: Non-Study Eye Intraocular Lens Exchange, Non-Study Eye, Full Thickness Macular Hole, Secondary Surgical Intervention: Non-Study Eye, Macular Hole Repair, Inpatient hospitalization following Hip Replacement Surgery, Inpatient hospitalization for Ventral Hernia Repair Surgery.
Data from ClinicalTrials.gov NCT05202808 adverse events section.
The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05202808.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing