Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
Overview
To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Screening
- Masking: None (Open Label)
- Study Primary Completion Date: January 2006
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).
Interventions
- 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
Arms, Groups and Cohorts
- Experimental: A
- 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
Clinical Trial Outcome Measures
Primary 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
Secondary Measures
- There are no secondary outcome measures specified for this study
- Time Frame: There are no secondary outcome measures specified for this study
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Asociación para Evitar la Ceguera en México
- Provider of Information About this Clinical Study
- Asociación para Evitar la Ceguera en México, Asociación para Evitar la Ceguera en México
- Overall Official(s)
- Ramirez F Manuel, MD, Principal Investigator, Asociación para Evitar la Ceguera en México
References
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.
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.
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.
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.
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