Femtosecond Laser Versus Microkeratome in Creating Corneal Flaps in LASIK
NCT ID: NCT03484468
Last Updated: 2018-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2018-04-30
2020-04-30
Brief Summary
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Detailed Description
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Aim of the work To evaluate and compare the variation in corneal flap thickness created from use of a femtosecond laser and a MORIA microkeratome when making a 110-µm- and 90- µm thick corneal flap and to identify the potential factors that affect corneal flap thickness.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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femtosecond_laser
participants had there lasik corneal flap creation using femtosecond laser
anterior segment Ocular Coherence Tomography
anterior segment OCT (Ocular Coherence Tomography) a device shows imaging of anterior segment of the eye and able to show corneal layers and measures its thickness.
moria_microkeratome
participants had there lasik corneal flap creation using moria microkeratome
anterior segment Ocular Coherence Tomography
anterior segment OCT (Ocular Coherence Tomography) a device shows imaging of anterior segment of the eye and able to show corneal layers and measures its thickness.
Interventions
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anterior segment Ocular Coherence Tomography
anterior segment OCT (Ocular Coherence Tomography) a device shows imaging of anterior segment of the eye and able to show corneal layers and measures its thickness.
Eligibility Criteria
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Inclusion Criteria
* Preoperative spherical refraction of -2.00 to -10.00D.
* Refractive cylinder of less than -3.00D.
* A stable refractive state for 2 years.
* An intraocular pressure (IOP) of \<22 mm Hg.
Exclusion Criteria
* A history of diabetes.
* Other ophthalmic disorders.
* A history of ocular trauma and surgical history.
18 Years
40 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Gerges Fargalla
Medicin Baccalaureus et Baccalaureus Chirurgi
Principal Investigators
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GERGES F. YOUNAN, M.B.B.CH.
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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Zhang J, Zhang SS, Yu Q, Wu JX, Lian JC. Comparison of corneal flap thickness using a FS200 femtosecond laser and a moria SBK microkeratome. Int J Ophthalmol. 2014 Apr 18;7(2):273-7. doi: 10.3980/j.issn.2222-3959.2014.02.14. eCollection 2014.
F.A.Guarnieri(ed.), Introduction, Corneal Biomechanics and Refractive Surgery, © Springer Science+Business Media New York 2015 ; 1: 1
Solomon KD, Fernandez de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701. doi: 10.1016/j.ophtha.2008.12.037.
Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: safety and efficacy: a report by the American Academy of Ophthalmology. Ophthalmology. 2002 Jan;109(1):175-87. doi: 10.1016/s0161-6420(01)00966-6.
Hsu SY, Chen HY, Chung CP. Analysis of actual corneal flap thickness and confounding factors between first and second operated eyes. Ophthalmic Surg Lasers Imaging. 2009 Sep-Oct;40(5):448-52. doi: 10.3928/15428877-20090901-02.
Ortiz D, Alio JL, Pinero D. Measurement of corneal curvature change after mechanical laser in situ keratomileusis flap creation and femtosecond laser flap creation. J Cataract Refract Surg. 2008 Feb;34(2):238-42. doi: 10.1016/j.jcrs.2007.09.023.
Reinstein DZ, Archer TJ, Gobbe M. The history of LASIK. J Refract Surg. 2012 Apr;28(4):291-8. doi: 10.3928/1081597X-20120229-01.
Soong HK, Malta JB. Femtosecond lasers in ophthalmology. Am J Ophthalmol. 2009 Feb;147(2):189-197.e2. doi: 10.1016/j.ajo.2008.08.026. Epub 2008 Oct 18.
Marino GK, Santhiago MR, Wilson SE. Femtosecond Lasers and Corneal Surgical Procedures. Asia Pac J Ophthalmol (Phila). 2017 Sep-Oct;6(5):456-464. doi: 10.22608/APO.2017163. Epub 2017 Jul 31.
Ratkay-Traub I, Ferincz IE, Juhasz T, Kurtz RM, Krueger RR. First clinical results with the femtosecond neodynium-glass laser in refractive surgery. J Refract Surg. 2003 Mar-Apr;19(2):94-103. doi: 10.3928/1081-597X-20030301-03.
Other Identifiers
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femtosecond_vs_microkeratome
Identifier Type: -
Identifier Source: org_study_id