Clinical trial NCT06428955: Evaluation of a Monofocal Intraocular Lens
Official title: Prospective Multicenter Evaluation of the Visual Performance of a Non-constant Aberration Correcting Aspheric Monofocal Intraocular Lens (Precise Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Monocular best corrected distance visual acuity (CDVA)
timeFrame: Three (3) Months
Secondary outcomes:
measure: Binocular Corrected Distance Visual Acuity
timeFrame: Three (3) Months
measure: Monocular Uncorrected Distance Visual Acuity
timeFrame: Three (3) Months
measure: Monocular Distance Corrected Intermediate Visual Acuity
timeFrame: Three (3) Months
measure: Monocular Uncorrected Intermediate Visual Acuity
timeFrame: Three (3) Months
measure: Manifest Refraction Spherical Equivalent
timeFrame: Three (3) Months
measure: Refractive Predictability
timeFrame: Three (3) Months
measure: Refractive Stability
timeFrame: Three (3) Months
measure: Contrast Sensitivity - mesopic and photopic with and without glare
timeFrame: Three (3) Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Lexington
country: United States
facility: Huffman & Huffman PSC
state: Kentucky
city: Hershey
country: United States
facility: The Pennsylvania State University and Penn State Health
state: Pennsylvania
city: Ciudad de México
country: Mexico
facility: Asociación Para Evitar La Ceguera en México, I.A.P.
state: Alcaldia Coyoacan
Study officials:
References: