Femtosecond Laser Versus Microkeratome in Creating Corneal Flaps in LASIK

Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps Clinical Trial

Official title:

Predictability of Corneal Flap Thickness in Lasik Using Femtosecod Laser in Comparison to Moria Microkeratome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03484468
• Other study ID #: femtosecond_vs_microkeratome
• Status: Not yet recruiting
• First received: March 24, 2018
• Last updated: March 24, 2018
• Start date: April 2018
• Est. completion date: April 2020

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: SAMIR Y. SALIH, PHD
• Phone: +201003304320
• Email: samir.abouelail[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since the cornea is the main responsible for the refraction of the eye, as its refractive power is greater than 70% of the total refraction of the eye, so modification of its refractive properties are used to change the optical system of the eye. Hence, laser-assisted in situ keratomileusis has become the most commonly procedure used to correct the refractive errors of the eye. The most important step in laser-assisted in situ keratomileusis is the creation of the corneal flap, which its thickness may judge the whole outcome of the surgery . So trying to minimize the variation in the thickness of the resultant flap in comparison to what planned flap thickness preoperatively become our target.

Description:

As laser-assisted in situ keratomileusis procedure started to use automated microkeratomes in creating corneal flaps since 1989, and science go on until United states Food and Drug Administration approved the IntraLase laser for flap creation in January 2000 femtosecond lasers work by emitting light pulses of short duration (10−15 s) at 1053 nm wavelength that cause photodisruption of the tissue with minimum collateral damage . This enables no blade incisions to be performed within the tissue at various patterns and depth with high precision.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 18-40 year

• 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 any systemic autoimmune disease.

• A history of diabetes.

• Other ophthalmic disorders.

• A history of ocular trauma and surgical history.

Related Conditions & MeSH terms

• Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

F.A.Guarnieri(ed.), Introduction, Corneal Biomechanics and Refractive Surgery, © Springer Science+Business Media New York 2015 ; 1: 1

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. — View Citation

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. Review. — View Citation

Ortiz D, Alió JL, Piñero 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. — View Citation

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. — View Citation

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. — View Citation

Solomon KD, Fernández 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;11 — View Citation

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. Review. — View Citation

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- — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	corneal flap thickness	measuring the corneal flap thickness in nanometers postoperatively by anterior segment OCT	7 days
Secondary	uncorrected visual acuity	identifying uncorrected visual acuity postoperatively	7 days
Secondary	best corrected visual acuity	identifying best corrected visual acuity postoperatively	7 days