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

Launched by UNIVERSITY CLINIC FRANKFURT · Feb 26, 2025

Keywords

ClinConnect Summary

The null hypothesis is that combined laser in situ keratomileusis (LASIK) with corneal UV-riboflavin crosslinking (LASIK-Xtra) has the same long-term safety and effectiveness as classic LASIK for the correction of myopia and myopic astigmatism.

Aim of the study The main objective of this study is to determine whether LASIK-Xtra compared to classic femto-LASIK

1. leads to the same long-term results in terms of postoperative visual acuity,
2. the postoperative spectacle values of both eyes are at least equally stable over several years after the study and
3. the corneal shape and stiffness ...

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)