Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Measured thickness flap using Confocal microscopy study [14 days after LASIK]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Belin MW, Schultze RL. Microkeratomes. Int Ophthalmol Clin. 2000 Summer;40(3):57-65. Review.
- Dougherty PJ. The thin-flap LASIK technique. J Refract Surg. 2005 Sep-Oct;21(5 Suppl):S650-4.
- 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.
- 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.
- 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.
- 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.
- Ismail MM. LASIK using the NIDEK EC-5000 for the correction of hyperopic astigmatism. J Refract Surg. 2006 Nov;22(9 Suppl):S1069-72.
- 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.
- 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.
- 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.
- Cornea 1