Trials / Completed
CompletedNCT04884178
PMCF Study of Preloaded Trifocal IOL
Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- ICARES Medicus, Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.
Detailed description
This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Trifocal Preloaded IOL Delivery System | UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan. |
Timeline
- Start date
- 2021-08-23
- Primary completion
- 2022-04-18
- Completion
- 2023-08-22
- First posted
- 2021-05-12
- Last updated
- 2024-04-19
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT04884178. Inclusion in this directory is not an endorsement.