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Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism
NA trial testing RxSight RxLAL in Cataract in 55 participants. Completed in 1 July 2020.
| Lead sponsor | RxSight, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 19 June 2018 |
| Primary completion | 1 July 2019 |
| Estimated completion | 1 July 2020 |
| Sites | 3 locations across United Kingdom, Germany |
RxSight, Inc.
40 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
| Group | Value | 95% CI |
|---|---|---|
| RxSight RxLAL IOL | 45 |
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
| Group | Value | 95% CI |
|---|---|---|
| RxSight RxLAL IOL | 3 |
Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.
| Group | Value | 95% CI |
|---|---|---|
| RxSight RxLAL IOL | 1 |
Time frame: Through study completion, an average of 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | RxSight RxLAL IOL |
|---|---|---|
| IOL Explant | Surgical and medical procedures | — |
| Gastritis with diarrhea | Gastrointestinal disorders | — |
| Reaction | System | RxSight RxLAL IOL |
|---|---|---|
| Non-clinically significant cystoid macular edema | Eye disorders | — |
| Diabetic macular edema | Eye disorders | — |
| Posterior Capsular Opacity | Eye disorders | — |
| Loss of BSCVA of ≥ 10 letters due to dry Eye | Eye disorders | — |
| Clinically significant cystoid macular edema | Eye disorders | — |
| Conjunctivitis | Eye disorders | — |
| Cornea Epithelialized with SPK | Eye disorders | — |
| Giant cells on anterior surface of IOL | Eye disorders | — |
| Loss of BCDVA due to Posterior Capsular Opacity | Eye disorders | — |
| Corneal Edema | Eye disorders | — |
| Blurred vision right eye | Eye disorders | — |
| Increased protein distribution after lock-in procedure | Eye disorders | — |
| Loss of BCDVA due to lens aberrations | Eye disorders | — |
Most-reported serious reactions: IOL Explant, Gastritis with diarrhea.
Data from ClinicalTrials.gov NCT03771352 adverse events section.
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.
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/NCT03771352.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing