Evaluation of a Monofocal Intraocular Lens
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Carl Zeiss Meditec AG
- Study ID
- NCT06428955
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Cataract
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- CT LUCIA 621P — DEVICEThe device under investigation, CT LUCIA 621P IOL (Carl Zeiss Meditec, Jena, Germany) is a posterior chamber intraocular lens which is indicated for aphakia after surgical extraction of the cataractous natural lens. It is a monofocal aspheric IOL made of hydrophobic material and coated with heparin. The modified C-loop haptic is step-vaulted.
Study Details
The aim of this study is to investigate the 3-month visual performance of the CT LUCIA 621P IOL, a hydrophobic aspheric monofocal IOL with a non-constant aspheric optic profile in adult patients 50 years of age or older who are undergoing cataract surgery.
Key Dates
- Start date
- Jun 6, 2024
- Status verified
- Jun 2024
- Primary completion
- Dec 31, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 44 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Bilateral implantation of investigational deviceMonofocal IOL
Primary Outcome Measure
Monocular best corrected distance visual acuity (CDVA) [ Time Frame: Three (3) Months ]
Central Contacts
- Grant Sharpe+447918937014
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Price Vision Group | Indianapolis | Indiana | 46260 | Marianne Price, MD Francis Price, MD (PRINCIPAL_INVESTIGATOR) |
| Huffman & Huffman PSC | Lexington | Kentucky | 40509 | Mark Huffman, MD Mark Huffman, MD (PRINCIPAL_INVESTIGATOR) |
| The Pennsylvania State University and Penn State Health | Hershey | Pennsylvania | 17033 | Amy Longenecker Seth Pantanelli, MD (PRINCIPAL_INVESTIGATOR) |
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