Evaluation of Cataract Surgery Outcomes in Patients With Prior Laser Vision Correction Implanted With the CT LUCIA Lens

🩺 Protocol 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.

Primary Research Facility: Berkeley Eye Center (Sugar Land, Texas)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

📍 Primary Site Map

Site: Berkeley Eye Center — Sugar Land, Texas

This protocol is enrolling participants across multiple clinical centers:

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.