Evaluation of a Monofocal Intraocular Lens

NCT06428955 | Recruiting Phase 4 FDA Device

• 1 other identifier: GPAS-SAS-023-01
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Monocular best corrected distance visual acuity (CDVA)

  The primary efficacy endpoint is the proportion of patients with monocular CDVA of 20/40 or better at three months

  Three (3) Months

Secondary Outcomes (8)

• Binocular Corrected Distance Visual Acuity

  Three (3) Months

• Monocular Uncorrected Distance Visual Acuity

  Three (3) Months

• Monocular Distance Corrected Intermediate Visual Acuity

  Three (3) Months

• Monocular Uncorrected Intermediate Visual Acuity

  Three (3) Months

• Manifest Refraction Spherical Equivalent

  Three (3) Months

Study Arms (1)

Bilateral implantation of investigational device

EXPERIMENTAL

Monofocal IOL

Device: CT LUCIA 621P

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.

Bilateral implantation of investigational device

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 50 years of age or older, male or female, of any race or ethnicity.
• Presenting for uncomplicated bilateral cataract surgery for age-related cataract.
• Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).
• Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D).
• Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)
• No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation.
• Provide written informed consent and a signed HIPPA form.
• Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

You may not qualify if:

• Corneal Astigmatism of \>1.0 D.
• Planned monocular cataract extraction.
• Visual field loss which has an impact on visual acuity.
• Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.
• History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, keratoconus, strabismus, uncontrolled glaucoma)
• History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.
• Previous intraocular or corneal surgery, including all forms of refractive surgery that might confound the outcome of the investigation or increase the risk to the subject
• Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT/ALT (e.g., vitrectomy, laser iridotomy)
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions).
• Capsular or zonular abnormalities or other conditions that increase the risk of zonular rupture during cataract extraction procedure and/or may affect the postoperative centration or tilt of the lens
• Use of a systemic or ocular medication that might affect vision and confound the outcome or increase the risk to the subject in the opinion of the investigator such as tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)
• Cycloplegic pupil diameter \<6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis).
• Usage of contact lenses during study participation
• Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes
• Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk or may confound the outcome of the study.

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (4)

Price Vision Group

Indianapolis, Indiana, 46260, United States

NOT YET RECRUITING

Huffman & Huffman PSC

Lexington, Kentucky, 40509, United States

RECRUITING

The Pennsylvania State University and Penn State Health

Hershey, Pennsylvania, 17033, United States

NOT YET RECRUITING

Asociación Para Evitar La Ceguera en México, I.A.P.

Mexico City, Alcaldia Coyoacan, C.P. 04030, Mexico

NOT YET RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Grant Sharpe

CONTACT

+447918937014; grant.sharpe@zeiss.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: June 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (3)