Clinical trial NCT00599690: Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
Official title: Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Corneal Epithelium
Keywords: Epi-LASIK-LASIK microkeratome
Corneal thickness
Confocal microscope
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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 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

Primary outcomes:
measure: A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy)
timeFrame: Before and at 2 weeks and 1 month after surgery
Secondary outcomes:
measure: There are no secondary outcome measures specified for this study
timeFrame: There are no secondary outcome measures specified for this study
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
state: Distrito Federal
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Ramirez F Manuel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.jcrs.2007.07.038.
citation: 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. doi: 10.3928/1081-597X-20071102-07.
citation: Katsanevaki VJ, Kalyvianaki MI, Kavroulaki DS, Pallikaris IG. One-year clinical results after epi-LASIK for myopia. Ophthalmology. 2007 Jun;114(6):1111-7. doi: 10.1016/j.ophtha.2006.08.052. Epub 2007 Feb 23.
citation: 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. doi: 10.1016/s0181-5512(07)89639-2. French.