Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut

Refractive Errors Clinical Trial

Official title:

Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00558324
• Other study ID #: Cornea 1
• Status: Terminated
• Phase: N/A
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: October 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Procedure:
• LASIK
Mechanical microkeratome Hansatome 160 microns
• LASIK
Mechanical microkeratome K 3000 130 microns
• LASIK
Femtoseconds laser 100 microns

Locations

Country	Name	City	State
Mexico	Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".	México city	Distrito Federal

Sponsors (2)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México	Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (12)

Belin MW, Schultze RL. Microkeratomes. Int Ophthalmol Clin. 2000 Summer;40(3):57-65. doi: 10.1097/00004397-200007000-00008. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measured thickness flap using Confocal microscopy study		14 days after LASIK