Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut - Full Text View

Purpose

Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.

Condition	Intervention
Refractive Errors	Procedure: LASIK

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening
Official Title:	Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut

Resource links provided by NLM:

MedlinePlus related topics: Refractive Errors

U.S. FDA Resources

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

Primary Outcome Measures:

Measured thickness flap using Confocal microscopy study [ Time Frame: 14 days after LASIK ]

Enrollment:	43
Study Start Date:	February 2007
Study Completion Date:	October 2007

Arms	Assigned Interventions
Experimental: I Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)	Procedure: LASIK Mechanical microkeratome Hansatome 160 microns
Experimental: II Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .	Procedure: LASIK Mechanical microkeratome K 3000 130 microns
Experimental: III Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)	Procedure: LASIK Femtoseconds laser 100 microns

Detailed Description:

Eighty-six eyes had undergone LASIK were examined, al within 2 weeks to 1 month after surgery. Study involved 3 treatment groups: One with 30 eyes of 15 patients, corneal flaps were created with the microkeratome femtosecond laser 15 KHz 100μm (Intralase Corp, Irvine, Calif.), one with 30 eyes of 15 patients, corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif) and one with 26 eyes of 13 patients, corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) . 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 ask for 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: NCT00558324

Locations

Mexico
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
México city, Distrito Federal, Mexico, 04030

Sponsors and Collaborators

Asociación para Evitar la Ceguera en México

Universidad Nacional Autonoma de Mexico

Investigators

Principal Investigator:	Ramírez F. Manuel, MD	Asociación para Evitar la Ceguera
Study Chair:	Ramírez G. Laura, MD	Asociación para Evitar la Ceguera

More Information

Publications:

Huhtala A, Pietilä J, Mäkinen P, Suominen S, Seppänen M, Uusitalo H. Corneal flap thickness with the Moria M2 single-use head 90 microkeratome. Acta Ophthalmol Scand. 2007 Jun;85(4):401-6.

Sarayba MA, Ignacio TS, Binder PS, Tran DB. Comparative study of stromal bed quality by using mechanical, IntraLase femtosecond laser 15- and 30-kHz microkeratomes. Cornea. 2007 May;26(4):446-51.

Hoffmann S, Krummenauer F, Tehrani M, Dick HB. Impact of head advance and oscillation rate on the flap parameter: a comparison of two microkeratomes. Graefes Arch Clin Exp Ophthalmol. 2003 Feb;241(2):149-53. Epub 2003 Jan 28.

Belin MW, Schultze RL. Microkeratomes. Int Ophthalmol Clin. 2000 Summer;40(3):57-65. Review. No abstract available.

Eisner RA, Binder PS. Technique for measuring laser in situ keratomileusis flap thickness using the IntraLase laser. J Cataract Refract Surg. 2006 Apr;32(4):556-8.

Durrie DS, Kezirian GM. Femtosecond laser versus mechanical keratome flaps in wavefront-guided laser in situ keratomileusis: prospective contralateral eye study. J Cataract Refract Surg. 2005 Jan;31(1):120-6.

Solomon KD, Donnenfeld E, Sandoval HP, Al Sarraf O, Kasper TJ, Holzer MP, Slate EH, Vroman DT; Flap Thickness Study Group. Flap thickness accuracy: comparison of 6 microkeratome models. J Cataract Refract Surg. 2004 May;30(5):964-77.

Ismail MM. LASIK using the NIDEK EC-5000 for the correction of hyperopic astigmatism. J Refract Surg. 2006 Nov;22(9 Suppl):S1069-72.

Dougherty PJ. The thin-flap LASIK technique. J Refract Surg. 2005 Sep-Oct;21(5 Suppl):S650-4.

Montés-Micó R, Rodríguez-Galietero A, Alió JL. Femtosecond laser versus mechanical keratome LASIK for myopia. Ophthalmology. 2007 Jan;114(1):62-8. Epub 2006 Oct 27.

Ramírez M, Hernández-Quintela E, Naranjo-Tackman R. A comparative confocal microscopy analysis after LASIK with the IntraLase femtosecond laser vs Hansatome microkeratome. J Refract Surg. 2007 Mar;23(3):305-7.

Ramírez M, Hernández-Quintela E, Sánchez-Huerta V, Naranjo-Tackman R. Confocal microscopy of corneal flap microfolds after LASIK. J Refract Surg. 2006 Feb;22(2):155-8.

ClinicalTrials.gov Identifier:	NCT00558324 History of Changes
Other Study ID Numbers:	Cornea 1
Study First Received:	November 7, 2007
Last Updated:	November 12, 2007
Health Authority:	Mexico: Ethics Committee

Keywords provided by Asociación para Evitar la Ceguera en México:

LASIK
Confocal microscopy
Flap

Additional relevant MeSH terms:

Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013