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Refractive ErrorsNCT00558324

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

A study testing LASIK in people with Refractive Errors, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Refractive Errors
What is being tested?
LASIK
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteMexico
Study dates
Feb 2007to Oct 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

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

    Mexico City, Mexico City, 04030

Other trials in Mexico

About this study

Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.

Read the 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).

Being tested
LASIK
Keywords
LASIK, Confocal microscopy, Flap
Medical subject headings
Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LASIKProcedure or surgery

    Mechanical microkeratome Hansatome 160 microns

  • LASIKProcedure or surgery

    Mechanical microkeratome K 3000 130 microns

  • LASIKProcedure or surgery

    Femtoseconds laser 100 microns

Study groups in NCT00558324
Study groupRoleWhat they receive
IExperimentalCorneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)
Receives: Procedure: LASIK
IIExperimentalCorneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
Receives: Procedure: LASIK
IIIExperimentalCorneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
Receives: Procedure: LASIK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measured thickness flap using Confocal microscopy study

    Measured: 14 days after LASIK

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionFeb 2007
  4. Study completionOct 2007

Why it stopped: Undefined

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558324
Sponsor's protocol ID
Cornea 1
Status last verified
May 2024
First submitted
7 Nov 2007
Last updated
30 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17559465

  • 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.

    PubMed 17457194

  • 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.

    PubMed 12605270

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

    PubMed 10941646

  • 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.

    PubMed 16698470

  • 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.

    PubMed 15721704

  • 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.

    PubMed 15130631

  • 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.

    PubMed 17444095

  • 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.

    PubMed 16212298

  • 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.

    PubMed 17070593

  • 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.

    PubMed 17385298

  • 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.

    PubMed 16523834

Questions about this trial

What is this clinical trial studying?

A study testing LASIK in people with Refractive Errors, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Undefined). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measured thickness flap using Confocal microscopy study (time frame: 14 days after LASIK). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558324, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.

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