Actively Recruiting
Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens
Led by Carl Zeiss Meditec AG · Updated on 2025-07-24
30
Participants Needed
2
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, Phase IV, post-approval observational study evaluating postoperative outcomes in patients with a history of myopic corneal laser vision correction (LVC) undergoing bilateral cataract surgery with implantation of the CT LUCIA 621P intraocular lens (IOL). Up to 30 subjects (60 eyes) will be enrolled across up to three U.S. investigational sites. The study will assess visual and refractive outcomes, including biometry, manifest refraction, and patient-reported visual function over a 3-month follow-up period.
CONDITIONS
Official Title
Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years of age or older.
- Have had previous corneal laser vision correction surgery for mild to moderate myopia (with or without astigmatism up to -6.0 D sphere) performed at least 1 year before implantation.
- Presenting for planned bilateral cataract extraction with in-the-bag posterior chamber IOL implantation via phacoemulsification with or without femtosecond laser assistance.
- Clear intraocular media except for cataract (no hyphema or vitreous hemorrhage).
- No corneal or retinal pathologies limiting visual acuity.
- Able to provide written informed consent and HIPAA authorization.
- Willing and able to comply with study visits and examination procedures with sufficient cognitive awareness.
You will not qualify if you...
- Implantation of an IOL other than the CT LUCIA 621P in either eye.
- Preoperative anterior corneal astigmatism of 1.00 D or greater or predicted postoperative astigmatism over 0.75 D at the spectacle plane.
- Visual field loss affecting visual acuity.
- Diagnosed degenerative visual disorders such as macular degeneration or other retinal diseases.
- Surgical complications preventing CT LUCIA 621P IOL implantation.
- Irregular corneal astigmatism, epithelial basement membrane dystrophy, chronic dry eye requiring ongoing treatment.
- More than one prior LVC procedure or complications from previous LVC needing additional surgery.
- Planned ocular surgery during the study except Nd:YAG capsulotomy.
- Acute or chronic diseases or ocular trauma that may confound results.
- Current diagnosis of cystoid macular edema, proliferative diabetic retinopathy, amblyopia, or other chronic ocular conditions confounding results.
- Moderate or severe glaucoma.
- Strabismus, forme fruste keratoconus, keratoconus, or other corneal pathologies affecting visual acuity measurement.
- Previous radial keratotomy.
- Previous corneal keratoplasty procedures.
- Previous anterior or posterior chamber surgeries like vitrectomy or laser iridotomy.
- Pupil abnormalities including non-reactive, tonic, abnormally shaped, or poorly dilating pupils.
- Capsular or zonular abnormalities impacting lens centration or tilt.
- Use of contact lenses during study participation.
- Concurrent participation in another device investigation.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Berkeley Eye Center
Sugar Land, Texas, United States, 77478
Actively Recruiting
2
Piedmont Eye Center
Lynchburg, Virginia, United States, 24502
Actively Recruiting
Research Team
H
Henry Heering
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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