Long-term Safety and Effectiveness of LASIK-Xtra Compared to Conventional LASIK

Launched by UNIVERSITY CLINIC FRANKFURT · Feb 26, 2025

Keywords

ClinConnect Summary

This study is looking at the long-term safety and effectiveness of LASIK when it includes corneal UV-riboflavin crosslinking (often called LASIK-Xtra) and how it compares to standard LASIK for correcting myopia and myopic astigmatism. It’s an observational study, so researchers will observe and compare outcomes in people who have already had these procedures, rather than testing a new drug. The goal is to see if LASIK-Xtra provides similar or better long-term vision results, whether people’s vision stays stable over several years, and whether the cornea remains strong and healthy over time. The main thing they will measure is the eye’s prescription after the procedure at one follow-up visit, along with safety checks for any adverse effects or corneal changes.

Who may be eligible: Adults 18 and older who previously took part in the earlier XtraLasik study at Goethe University Frankfurt are being invited to participate. To join the new part, participants must be able to understand and sign consent, and not be employees or close relatives of ophthalmology companies. Participants will have a single study visit that includes a corneal eye exam, a test to determine their prescription, and special eye imaging tests to check corneal shape, strength, and eye pressure. The study is currently enrolling by invitation in Frankfurt, started in 2024, and aims to complete around late 2025; results are not yet available. Data privacy is maintained by using numeric IDs, and no personal data will be shared.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For both the retrospective and prospective part of the study:
• • 1. only patients who have successfully participated in the study with the clinicaltrials.gov registration number NCT 03913338 during the study period from 2014 to 2018 at the Department of Ophthalmology of the Goethe University Frankfurt will be included for the study to assess long-term outcomes and safety.
• • 2. adult men or women over the age of 18.
• • 3. subjects must be able to understand the requirements of the study and provide written informed consent.
• Exclusion Criteria:
• Applies only to patients participating in the prospective part of the study:
• • 1. employees, relatives or friends of employees of an ophthalmological company or investigational clinic (e.g. investigator, coordinator, technician)