Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

• Sponsor: Asociación para Evitar la Ceguera en México (Other)
• Overall Status: Completed
• CT.gov ID: NCT00599690
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Epithelium	Procedure: Epi-LASK	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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	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

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. There are no secondary outcome measures specified for this study [There are no secondary outcome measures specified for this study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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, Asociación para Evitar la Ceguera en México

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00599690
• Other Study ID Numbers: Cornea 3
• First Posted: Jan 24, 2008
• Last Update Posted: Jan 29, 2008
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: Epi-LASIK-LASIK microkeratome; Corneal thickness; Confocal microscope

Study Results

No Results Posted as of Jan 29, 2008