Trials / Completed
CompletedNCT05069415
Monofocal IOL Visual Outcomes When Targeting Mini Monovision
Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Carolina Eyecare Physicians, LLC · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Eyhance IOL | Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. |
| DEVICE | Eyhance IOL | Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
Timeline
- Start date
- 2021-10-04
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2021-10-06
- Last updated
- 2024-02-13
- Results posted
- 2024-02-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05069415. Inclusion in this directory is not an endorsement.