Trials / Completed
CompletedNCT03347981
Clinical Study to Compare Visual Performance of Two Trifocal IOLs
Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Beaver-Visitec International, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
Detailed description
This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F. The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected. Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IOL implantation experimental | Implantation of trifocal IOL POD F GF consisting of hydrophobic material |
| DEVICE | IOL implantation active comparator | Implantation of trifocal IOL POD F consisting of hydrophilic material |
Timeline
- Start date
- 2017-10-02
- Primary completion
- 2019-05-21
- Completion
- 2019-05-21
- First posted
- 2017-11-20
- Last updated
- 2021-05-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03347981. Inclusion in this directory is not an endorsement.