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

NCT00558324 | Terminated DMC

• 1 other identifier: Cornea 1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors

Keywords

LASIK; Confocal microscopy; Flap

Outcome Measures

Primary Outcomes (1)

• Measured thickness flap using Confocal microscopy study

  14 days after LASIK

Study Arms (3)

I

EXPERIMENTAL

Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)

Procedure: LASIK

II

EXPERIMENTAL

Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .

Procedure: LASIK

III

EXPERIMENTAL

Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)

Procedure: LASIK

Interventions

LASIK PROCEDURE

Mechanical microkeratome Hansatome 160 microns

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients cannot attend their appointments
• Residual, recurrent or active ocular disease
• Previous ocular surgery except LASIK
• Autoimmune or connective tissue disease
• Pregnancy

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".

Mexico City, Mexico City, 04030, Mexico

Location

Related Publications (12)

• 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.

  PMID: 17559465 BACKGROUND

• 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.

  PMID: 17457194 BACKGROUND

• 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.

  PMID: 12605270 BACKGROUND

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

  PMID: 10941646 BACKGROUND

• 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.

  PMID: 16698470 BACKGROUND

• 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.

  PMID: 15721704 BACKGROUND

• 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.

  PMID: 15130631 BACKGROUND

• 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.

  PMID: 17444095 BACKGROUND

• 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.

  PMID: 16212298 BACKGROUND

• 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.

  PMID: 17070593 BACKGROUND

• 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.

  PMID: 17385298 BACKGROUND

• 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.

  PMID: 16523834 BACKGROUND

MeSH Terms

Conditions

Refractive Errors

Interventions

Keratomileusis, Laser In Situ

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Ramírez F. Manuel, MD

  Asociación para Evitar la Ceguera

  PRINCIPAL INVESTIGATOR

• Ramírez G. Laura, MD

  Asociación para Evitar la Ceguera

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 14, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)