Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted … (NCT07084545) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens
United States30 participantsStarted 2025-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be at least 18 years of age or older.
. Previous cornea LVC surgery performed at least 1 year before the implantation of the CT LUCIA 621P IOL, such as Laser-Assisted Intrastromal Keratomileusis (LASIK), Laser-Assisted Subepithelial Keratectomy (LASEK), Photorefractive Keratectomy (PRK) or Small Incision Lenticule Extraction (SMILE) for mild to moderate myopia, with or without astigmatism (up to, but not including, -6.0 D sphere in any meridian for myopic ablations.
. Presenting for planned bilateral cataract extraction with in-the-bag posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS). Astigmatism management techniques, such as Astigmatic Keratotomy (AK), may be utilized during cataract surgery to target a predicted postoperative cylinder less than 0.75 D.
. Clear intraocular media other than cataract (i.e., no hyphema, vitreous hemorrhage).
. No visual acuity limiting corneal or retinal pathologies.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Prediction Error (PE)
Timeframe: 3 months postoperatively
2
Median Prediction Error (PE)
Timeframe: 3 months postoperatively
3
Absolute Prediction Error (PE)
Timeframe: 3 months postoperatively
4
Percentage of Eyes Within ±0.25 D of Predicted MRSE
Timeframe: 3 months postoperatively
5
Percentage of Eyes Within ±0.50 D of Predicted MRSE
Timeframe: 3 months postoperatively
6
Percentage of Eyes Within ±1.00 D of Predicted MRSE
. Able to and having provided written informed consent and a signed Health Insurance Portability and Accountability Act (HIPAA) form.
. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations.
Exclusion criteria
. Implantation of an IOL other than the CT LUCIA 621P in one or both eyes.
. Eyes with preoperative anterior corneal astigmatism of ΔTK ≥1.00 D as measured by the IOLMaster 700 or with greater than 0.75 D predicted post-operative astigmatism at the spectacle plane.
. Visual field loss which has an impact on visual acuity.
. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that would confound visual acuity measurement.
. Subjects with surgical complications in whom a CT LUCIA 621P IOL cannot be implanted in either eye.
. Eyes with irregular corneal astigmatism, epithelial basement membrane dystrophy, chronic dry eye requiring continual treatment, underwent more than one LVC procedure in one or both eyes, or complications from the previous LVC which required additional surgical intervention.
. Subjects with planned ocular surgery during the study (except Nd:YAG capsulotomy is permitted).
. History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the opinion of the investigator, confound results.