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Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia

NCT03913338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-04-12

No results posted yet for this study

Summary

The objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE) and keratometry.

Conditions

  • Myopia
  • Myopic Astigmatism
  • Crosslinking
  • Corneal Ectasia
  • Myopic Regression

Interventions

PROCEDURE

LasikXtra

By randomized selection, one eye was treated with the LASIK Xtra procedure that consists of fs-LASIK treatment combined with intraoperative accelerated continuous UV-riboflavin crosslinking. After laser ablation, the corneal bed under the flap was coated with riboflavin, rinsed with saline solution, and after 90 seconds the corneal flap was repositioned. The eye was irradiated at 30 mW/cm2 for 90 seconds with continuous UVA.

PROCEDURE

LASIK

Femtosecond-assisted preparation of a corneal flap and subsequently excimer-laser ablation of corneal stroma. Repositioning of the corneal flap and installation of a therapeutic contact lens.

Sponsors & Collaborators

  • Glaukos Corporation

    collaborator INDUSTRY

  • University Clinic Frankfurt

    lead OTHER

Principal Investigators

  • Thomas Kohnen, Prof. Dr. · Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-24
Primary Completion
2018-07-03
Completion
2018-07-03

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913338 on ClinicalTrials.gov