Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut
NCT ID: NCT00558324
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
43 participants
INTERVENTIONAL
2007-02-28
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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I
Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)
LASIK
Mechanical microkeratome Hansatome 160 microns
II
Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
LASIK
Mechanical microkeratome K 3000 130 microns
III
Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
LASIK
Femtoseconds laser 100 microns
Interventions
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LASIK
Mechanical microkeratome Hansatome 160 microns
LASIK
Mechanical microkeratome K 3000 130 microns
LASIK
Femtoseconds laser 100 microns
Eligibility Criteria
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Inclusion Criteria
* Patients with stable refraction in the last year
* Patients without systemic and ocular disease
* Patients with 500 microns in pachymetry
* Normal topography
Exclusion Criteria
* Residual, recurrent or active ocular disease
* Previous ocular surgery except LASIK
* Autoimmune or connective tissue disease
* Pregnancy
18 Years
ALL
Yes
Sponsors
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Universidad Nacional Autonoma de Mexico
OTHER
Asociación para Evitar la Ceguera en México
OTHER
Principal Investigators
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Ramírez F. Manuel, MD
Role: PRINCIPAL_INVESTIGATOR
Asociación para Evitar la Ceguera
Ramírez G. Laura, MD
Role: STUDY_CHAIR
Asociación para Evitar la Ceguera
Locations
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Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
Mexico City, Mexico City, Mexico
Countries
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References
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Huhtala A, Pietila J, Makinen P, Suominen S, Seppanen M, Uusitalo H. Corneal flap thickness with the Moria M2 single-use head 90 microkeratome. Acta Ophthalmol Scand. 2007 Jun;85(4):401-6. doi: 10.1111/j.1600-0420.2006.00838.x.
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. doi: 10.1097/ICO.0b013e318033e7cc.
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. doi: 10.1007/s00417-002-0599-z. Epub 2003 Jan 28.
Belin MW, Schultze RL. Microkeratomes. Int Ophthalmol Clin. 2000 Summer;40(3):57-65. doi: 10.1097/00004397-200007000-00008. 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. doi: 10.1016/j.jcrs.2006.01.003.
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. doi: 10.1016/j.jcrs.2004.09.046.
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. doi: 10.1016/j.jcrs.2004.01.023.
Ismail MM. LASIK using the NIDEK EC-5000 for the correction of hyperopic astigmatism. J Refract Surg. 2006 Nov;22(9 Suppl):S1069-72. doi: 10.3928/1081-597X-20061102-11.
Dougherty PJ. The thin-flap LASIK technique. J Refract Surg. 2005 Sep-Oct;21(5 Suppl):S650-4. doi: 10.3928/1081-597X-20050902-19.
Montes-Mico R, Rodriguez-Galietero A, Alio JL. Femtosecond laser versus mechanical keratome LASIK for myopia. Ophthalmology. 2007 Jan;114(1):62-8. doi: 10.1016/j.ophtha.2006.07.019. Epub 2006 Oct 27.
Ramirez M, Hernandez-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. doi: 10.3928/1081-597X-20070301-15.
Ramirez M, Hernandez-Quintela E, Sanchez-Huerta V, Naranjo-Tackman R. Confocal microscopy of corneal flap microfolds after LASIK. J Refract Surg. 2006 Feb;22(2):155-8. doi: 10.3928/1081-597X-20060201-13.
Other Identifiers
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Cornea 1
Identifier Type: -
Identifier Source: org_study_id
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