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

• Sponsor: University Clinic Frankfurt (Other)
• Overall Status: Completed
• CT.gov ID: NCT03913338
• Collaborator: Glaukos Corporation (Industry)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 47.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Myopic Astigmatism; Crosslinking; Corneal Ectasia; Myopic Regression	Procedure: LasikXtra; Procedure: LASIK	N/A

Detailed Description

This is a controlled study of the safety and efficacy of the KXL System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA) for performing crosslinking in eyes undergoing LASIK for high myopia or myopic astigmatism. Each subject will have bilateral LASIK performed and one eye will be randomized to undergo LASIK followed by crosslinking.

Subjects will undergo bilateral LASIK. Following randomisation one eye of each subject will be treated with VibeX Xtra (Riboflavin Ophthalmic Solution) following LASIK and will be irradiated with the KXL System at 30 mW/cm2 intensity for 90 seconds continuous UV-A light treatment for a total radiant exposure of 2.7 J /cm2.

All eyes will be assessed at 1 day, 1, 3, 6, and 12 months after treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, intra-patient controlled, clinical trialProspective, randomized, intra-patient controlled, clinical trial
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Controlled Evaluation of the Safety and Efficacy of Laser In-situ Keratomileusis With Crosslinking (XtraLASIK) Compared to Conventional LASIK (convLASIK) in Patients With High Myopia
• Actual Study Start Date: Jul 24, 2014
• Actual Primary Completion Date: Jul 3, 2018
• Actual Study Completion Date: Jul 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Study group LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.	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.
Other: Control group LASIK only	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.

Outcome Measures

Primary Outcome Measures

1. uncorrected distant visual acuity [12 months postoperative]

   uncorrected distant visual acuity (logarithmic minimum angle of resolution)

2. best spectacle corrected distant visual acuity [12 months postoperative]

   best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)

3. spherical equivalent [12 months postoperative]

   spherical equivalent (diopter)

Secondary Outcome Measures

1. endothelial cell count [12 months postoperative]

   endothelial cell count (number of cells/ mm2)

2. Corneal thickness [12 months postoperative]

   Corneal thickness (micro millimeter)

3. Subjective visual quality [12 months postoperative]

   Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• eligible for bilateral myopic fs-LASIK with -6.00 to -12.00 D (diopters) with a maximum of 5.00 D astigmatism

• age > 18 years

• provided written informed consent

• difference between the MRSE and cycloplegic SE less than 0.75 D

• MRSE needed to be stable for the last 12 months (<0.5 D).

Exclusion Criteria:

• prior corneal surgery,

• forme fruste or manifest keratoconus,

• history of corneal scarring, melting, ulceration

• repeating inflammations of the eye

• taking vitamin C 1 week prior to the treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of ophthalmology University clinic Frankfurt	Frankfurt am Main	Hessen	Germany	60590

Sponsors and Collaborators

• University Clinic Frankfurt
• Glaukos Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Dr. med. Thomas Kohnen, Head of Ophthalmology, Principal Investigator, Clinical Professor, University Clinic Frankfurt
• ClinicalTrials.gov Identifier: NCT03913338
• Other Study ID Numbers: 154/14
• First Posted: Apr 12, 2019
• Last Update Posted: Apr 12, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Astigmatism

Study Results

No Results Posted as of Apr 12, 2019