Actively Recruiting
Evaluation of a Monofocal Intraocular Lens
Led by Carl Zeiss Meditec AG · Updated on 2024-06-24
44
Participants Needed
4
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of a Monofocal Intraocular Lens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �b10.50 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 will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Price Vision Group
Indianapolis, Indiana, United States, 46260
Not Yet Recruiting
2
Huffman & Huffman PSC
Lexington, Kentucky, United States, 40509
Actively Recruiting
3
The Pennsylvania State University and Penn State Health
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
4
Asociación Para Evitar La Ceguera en México, I.A.P.
Mexico City, Alcaldia Coyoacan, Mexico, C.P. 04030
Not Yet Recruiting
Research Team
G
Grant Sharpe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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