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

NCT03913338 | Completed

• 1 other identifier: 154/14
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Myopic Astigmatism; Crosslinking; Corneal Ectasia; Myopic Regression

Outcome Measures

Primary Outcomes (3)

• uncorrected distant visual acuity

  uncorrected distant visual acuity (logarithmic minimum angle of resolution)

  12 months postoperative

• best spectacle corrected distant visual acuity

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

  12 months postoperative

• spherical equivalent

  spherical equivalent (diopter)

  12 months postoperative

Secondary Outcomes (3)

• endothelial cell count

  12 months postoperative

• Corneal thickness

  12 months postoperative

• Subjective visual quality

  12 months postoperative

Study Arms (2)

Study group

OTHER

LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap.

Procedure: LasikXtra

Control group

OTHER

LASIK only

Procedure: LASIK

Interventions

LasikXtra PROCEDURE

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.

Study group

LASIK PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Clinic Frankfurt: lead
• Glaukos Corporation: collaborator

Study Sites (1)

Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Thomas Kohnen, Prof. Dr.

  Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology, Principal Investigator, Clinical Professor

Model Details: Prospective, randomized, intra-patient controlled, clinical trial

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 12, 2019
• Study Start: July 24, 2014
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

DE (1)