CompletedNot Applicable

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

Germany26 participantsStarted 2014-07-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

uncorrected distant visual acuity

Timeframe: 12 months postoperative

best spectacle corrected distant visual acuity

Timeframe: 12 months postoperative

spherical equivalent

Timeframe: 12 months postoperative

Trial details

NCT IDNCT03913338

SponsorUniversity Clinic Frankfurt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-03

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