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Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
This study has been completed.
Sponsored by: Asociación para Evitar la Ceguera en México
Information provided by: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00599690
  Purpose

To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.


Condition Intervention
Corneal Epithelium
 Procedure: Epi-LASK

U.S. FDA Resources
Study Type:
Interventional
Study Design:
Screening, Open Label, Uncontrolled, Single Group Assignment
Official Title:
Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) [ Time Frame: Before and at 2 weeks and 1 month after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • There are no secondary outcome measures specified for this study [ Time Frame: There are no secondary outcome measures specified for this study ] [ Designated as safety issue: Yes ]

Enrollment:
10
Study Start Date:
January 2006
Study Completion Date:
September 2007
Primary Completion Date:
January 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes
Procedure: Epi-LASK
10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes

Detailed Description:

10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

  Eligibility
Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
Yes
Criteria

Inclusion Criteria:

  • Patients asking for epi-LASIK surgery
  • Patients with stable refraction in the last year
  • Patients without systemic and ocular disease
  • Patients with 500 microns in pachymetry
  • Normal topography

Exclusion Criteria:

  • Patients cannot attend their appointments
  • Residual, recurrent or active ocular disease
  • Previous ocular surgery except LASIK
  • Autoimmune or connective tissue disease
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599690

Locations
Mexico, Distrito Federal
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Mexico city, Distrito Federal, Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Principal Investigator: Ramirez F Manuel, MD APEC
  More Information

Publications:
Kollias A, Ulbig MW, Spitzlberger GM, Abdallat WH, Froehlich S, Welge-Luessen U, Lackerbauer CA. Epi-LASIK using the Amadeus II microkeratome: evaluation of cut quality using light and electron microscopy. J Cataract Refract Surg. 2007 Dec;33(12):2118-21.
Gamaly TO, El Danasoury A, El Maghraby A. A prospective, randomized, contralateral eye comparison of epithelial laser in situ keratomileusis and photorefractive keratectomy in eyes prone to haze. J Refract Surg. 2007 Nov;23(9 Suppl):S1015-20.
Katsanevaki VJ, Kalyvianaki MI, Kavroulaki DS, Pallikaris IG. One-year clinical results after epi-LASIK for myopia. Ophthalmology. 2007 Jun;114(6):1111-7. Epub 2007 Feb 23.
Hoang-Xuan T, Arnaud D, Souissi K, Cornu S. [Epi-LASIK, a novel surface photoablation technique] J Fr Ophtalmol. 2007 May;30(5):535-8. French.

Responsible Party:
Asociación para Evitar la Ceguera en México ( Asociación para Evitar la Ceguera en México )
Study ID Numbers:
Cornea 3, No
First Received:
January 8, 2008
Last Updated:
January 28, 2008
ClinicalTrials.gov Identifier:
NCT00599690  
Health Authority:
Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:
Epi-LASIK-LASIK microkeratome
Corneal thickness
Confocal microscope

ClinicalTrials.gov processed this record on January 07, 2009



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