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 — DEVICE
    The 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 device
    Monofocal IOL

Primary Outcome Measure

Monocular best corrected distance visual acuity (CDVA) [ Time Frame: Three (3) Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Price Vision GroupIndianapolisIndiana46260
Marianne Price, MD
Francis Price, MD (PRINCIPAL_INVESTIGATOR)
Huffman & Huffman PSCLexingtonKentucky40509
Mark Huffman, MD
Mark Huffman, MD (PRINCIPAL_INVESTIGATOR)
The Pennsylvania State University and Penn State HealthHersheyPennsylvania17033
Amy Longenecker
Seth Pantanelli, MD (PRINCIPAL_INVESTIGATOR)

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