Evaluating a new lens for cataract surgery

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

This study is testing a new type of lens for cataract surgery to see how well it helps people aged 50 and older see better and feel satisfied three months after the procedure.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Carl Zeiss Meditec AG (Industry-sponsored)
• Locations: 4 sites (Indianapolis, Indiana and 3 other locations)
• Trial ID: NCT06428955 on ClinicalTrials.gov

What this trial studies

This study investigates the visual performance of the CT LUCIA 621P intraocular lens (IOL) in adult patients aged 50 and older undergoing cataract surgery. Participants will receive bilateral implantation of this hydrophobic aspheric monofocal IOL, which features a non-constant aspheric optic profile. The study aims to assess the outcomes three months post-surgery, focusing on visual acuity and overall satisfaction with the lens. The intervention includes phacoemulsification with or without femtosecond laser assistance for cataract extraction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 and older who are scheduled for uncomplicated bilateral cataract surgery.

Not a fit: Patients with other visual acuity limiting pathologies or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance visual outcomes for patients undergoing cataract surgery with the new lens design.

How similar studies have performed: Other studies have shown positive outcomes with similar intraocular lens designs, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Indianapolis, Indiana and 3 other locations

• Price Vision Group — Indianapolis, Indiana, United States (Not_yet_recruiting)
• Huffman & Huffman PSC — Lexington, Kentucky, United States (Recruiting)
• The Pennsylvania State University and Penn State Health — Hershey, Pennsylvania, United States (Not_yet_recruiting)
• Asociación Para Evitar La Ceguera en México, I.A.P. — Mexico City, Alcaldia Coyoacan, Mexico (Not_yet_recruiting)

Study contacts

• Study coordinator: Grant Sharpe

Conditions Cataract