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

Primary Purpose

Refractive Errors

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

LASIK

About this trial

This is an interventional screening trial for Refractive Errors focused on measuring LASIK, Confocal microscopy, Flap

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

III

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Measured thickness flap using Confocal microscopy study

Secondary Outcome Measures

Full Information

NCT ID

NCT00558324

First Posted

November 7, 2007

Last Updated

November 12, 2007

Sponsor

Asociación para Evitar la Ceguera en México

Collaborators

Universidad Nacional Autonoma de Mexico

1. Study Identification

Unique Protocol Identification Number

NCT00558324

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

Collaborators

Universidad Nacional Autonoma de Mexico

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Errors

Keywords

LASIK, Confocal microscopy, Flap

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

III

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

LASIK

Intervention Description

Mechanical microkeratome Hansatome 160 microns

Intervention Type

Procedure

Intervention Name(s)

LASIK

Intervention Description

Mechanical microkeratome K 3000 130 microns

Intervention Type

Procedure

Intervention Name(s)

LASIK

Intervention Description

Femtoseconds laser 100 microns

Primary Outcome Measure Information:

Title

Measured thickness flap using Confocal microscopy study

Time Frame

14 days after LASIK

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramírez F. Manuel, MD

Organizational Affiliation

Asociación para Evitar la Ceguera

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ramírez G. Laura, MD

Organizational Affiliation

Asociación para Evitar la Ceguera

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

México city

State/Province

Distrito Federal

ZIP/Postal Code

04030

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

17559465

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.

Results Reference

background

PubMed Identifier

17457194

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.

Results Reference

background

PubMed Identifier

12605270

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.

Results Reference

background

PubMed Identifier

10941646

Citation

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

Results Reference

background

PubMed Identifier

16698470

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.

Results Reference

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PubMed Identifier

15721704

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.

Results Reference

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PubMed Identifier

15130631

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.

Results Reference

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PubMed Identifier

17444095

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.

Results Reference

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PubMed Identifier

16212298

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.

Results Reference

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PubMed Identifier

17070593

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.

Results Reference

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PubMed Identifier

17385298

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.

Results Reference

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PubMed Identifier

16523834

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.

Results Reference

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

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