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

NCT06857032 | Enrolling By Invitation

• 1 other identifier: 0219-2024
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Laser in situ keratomileusis (LASIK) is a widely used procedure for the correction of myopia and myopic astigmatism. Despite its high effectiveness and the general safety of the procedure, long-term safety and effectiveness remain a key concern in ophthalmology. A promising further development is the combination of LASIK with corneal UV-riboflavin crosslinking, which promises additional stability of the cornea.1 This study aims to evaluate the long-term safety and effectiveness of this combined method in comparison to classic LASIK. By analysing long-term results, the aim is to gain well-founded insights that will help to optimise the decision on the most suitable procedure for correcting myopia and myopic astigmatism and to ensure the best possible clinical results for patients.

Conditions

Tomography; Corneal Biomechanics; Manifest Ref; Endothelial Cells; IOP; Optical Coherence Tomography

Keywords

Lasik; Lasik Xtra; Keratectasia; Corneal biomechanics

Outcome Measures

Primary Outcomes (1)

• Manifest refraction

  Manifest refraction with trial frame

  single time point with one and only visit

Study Arms (1)

Group 1

Patients treated with Xtralasik

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Xtralasik and participated in the first XtraLasik study

You may qualify if:

• For both the retrospective and prospective part of the study:
• 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.
• adult men or women over the age of 18.
• subjects must be able to understand the requirements of the study and provide written informed consent.

You may not qualify if:

• Applies only to patients participating in the prospective part of the study:
• \. employees, relatives or friends of employees of an ophthalmological company or investigational clinic (e.g. investigator, coordinator, technician)

Sponsors & Collaborators

• University Clinic Frankfurt: lead

Study Sites (1)

University Clinic Frankfurt, Goethe University

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

• Kohnen T, Lwowski C, Hemkeppler E, de'Lorenzo N, Petermann K, Forster R, Herzog M, Bohm M. Comparison of Femto-LASIK With Combined Accelerated Cross-linking to Femto-LASIK in High Myopic Eyes: A Prospective Randomized Trial. Am J Ophthalmol. 2020 Mar;211:42-55. doi: 10.1016/j.ajo.2019.10.024. Epub 2019 Nov 1.

  PMID: 31678559 BACKGROUND

Study Officials

• Thomas Kohnen, Professor and Doctor

  University Hospital Frankfurt am Main - Eye clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)