Trials / Terminated
TerminatedNCT04177771
A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus
A Prospective Randomized Controlled Multi-center Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus
- Status
- Terminated
- Phase
- —
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- RxSight, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population | Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments |
| DEVICE | SofPort LI61AO IOL | Control treatment group will receive SofPort LI61AO IOL |
| DEVICE | Tecnis ZCB00 or ZTC150 IOL | Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL |
Timeline
- Start date
- 2019-11-15
- Primary completion
- 2021-12-20
- Completion
- 2021-12-20
- First posted
- 2019-11-26
- Last updated
- 2025-01-07
- Results posted
- 2025-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04177771. Inclusion in this directory is not an endorsement.