Evaluation of a Monofocal Intraocular Lens (PRECISE)

Prospective Multicenter Evaluation of the Visual Performance of a Non-constant Aberration Correcting Aspheric Monofocal Intraocular Lens (Precise Study))

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: CT LUCIA 621P

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Grant Sharpe; Phone Number: +447918937014; Email: grant.sharpe@zeiss.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be at least 50 years of age or older, male or female, of any race or ethnicity.
2. Presenting for uncomplicated bilateral cataract surgery for age-related cataract.
3. Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS).
4. 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).
5. Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage)
6. 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.
7. Provide written informed consent and a signed HIPPA form.
8. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.

Exclusion Criteria:

1. Corneal Astigmatism of >1.0 D.
2. Planned monocular cataract extraction.
3. Visual field loss which has an impact on visual acuity.
4. Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted.
5. 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)
6. History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.
7. 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
8. Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT/ALT (e.g., vitrectomy, laser iridotomy)
9. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions).
10. 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
11. 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)
12. Cycloplegic pupil diameter <6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis).
13. Usage of contact lenses during study participation
14. Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral implantation of investigational device; Monofocal IOL	Device: CT LUCIA 621P; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Corrected Distance Visual Acuity		Three (3) Months
Binocular Uncorrected Corrected Distance Visual Acuity		Three (3) Months
Monocular Uncorrected 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
Refractive Predictability	Manifest refraction will be evaluated at 1 and 3 months to determine refractive predictability. The predicted refraction is the goal or target refraction from the IOLMaster IOL calculation and the observed refraction is the 3 Month postoperative Manifest Refraction Spherical Equivalent measurement.	Three (3) Months
Refractive Stability	Manifest refraction will be obtained at 1 and 3 months to evaluate whether refractive stability is achieved by 3 months. Refractive stability will be evaluated at the 1 to 3 months interval as a parameter of interest to determine the proportion of eyes that achieve stability of manifest refraction.	Three (3) Months
Contrast Sensitivity - mesopic and photopic with and without glare		Three (3) Months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GPAS-SAS-023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes