Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery

Brief Title

Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery

Official Title

Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery

Brief Summary

      The aim of the study is to examine the effect of fresh corneal lenticule implantation as
      allogenic graft taken from myopic patients to implanted in patients with macular corneal
      dystrophy using Visumax Femtosecond Laser Smile module surgery.

Detailed Description

      Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by
      bilateral cloudy regions within hazy stroma and eventually severe visual impairment.

      Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in
      the production of keratan sulfate, which plays a role in the maintenance of corneal

      According to biomechanical instability of corneal metabolism (abnormal increase collagenase
      activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase
      cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum
      contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix
      which contribute to the regeneration of the cornea, and all this results at increasing of
      corneal transparency and visual acuity in patients with corneal macular dystrophy.

Study Type


Primary Outcome

Increase of corneal transparency

Secondary Outcome

 Increase of visual acuity


Macular Corneal Dystrophy


Fresh Corneal Lenticule Implantation using Relex-Smile Surgery

Study Arms / Comparison Groups

 ReLex Smile surgery
Description:  The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

June 1, 2019

Completion Date

June 1, 2022

Primary Completion Date

June 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  indications for penetrating keratoplasty

          -  low transparec of corneae

          -  low visual acuity

        Exclusion Criteria:

          -  active anterior segment pathology

          -  previous corneal or anterior segment surgery

          -  any infection




20 Years - 55 Years

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Eye Hospital Pristina Kosovo

Study Sponsor

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Verification Date

November 2020