Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal FlapsNCT03484468
Femtosecond Laser Versus Microkeratome in Creating Corneal Flaps in LASIK
An observational study of Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps
- What is being tested?
- anterior segment Ocular Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2020
- Phase
- Observational
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: population attending specialized eye centers
Who may be able to join
- 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.
Who cannot join
- A history of any systemic autoimmune disease.
- A history of diabetes.
- Other ophthalmic disorders.
- A history of ocular trauma and surgical history.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Predictability of Corneal Flap Thickness in Lasik Using Femtosecod Laser in Comparison to Moria Microkeratome
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.
Read the detailed 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.
- Being tested
- anterior segment Ocular Coherence Tomography
- Keywords
- lasik, flap_thickness, femtosecond, laser, moria, microkeratome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior segment Ocular Coherence TomographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| femtosecond_laser | participants had there lasik corneal flap creation using femtosecond laser Receives: Device: anterior segment Ocular Coherence Tomography | |
| moria_microkeratome | participants had there lasik corneal flap creation using moria microkeratome Receives: Device: anterior segment Ocular Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal flap thickness
measuring the corneal flap thickness in nanometers postoperatively by anterior segment OCT
Measured: 7 days
Secondary outcomes (2)
uncorrected visual acuity
identifying uncorrected visual acuity postoperatively
Measured: 7 days
best corrected visual acuity
identifying best corrected visual acuity postoperatively
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal FlapsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerges Fargalla, Assiut University
- Investigators
- GERGES F. YOUNAN, M.B.B.CH., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484468
- Sponsor's protocol ID
- femtosecond_vs_microkeratome
- Status last verified
- Mar 2018
- First submitted
- 24 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24790869F.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.
PubMed 19344821Sugar 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.
PubMed 11772601Hsu 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.
PubMed 19772267Ortiz 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.
PubMed 18242446Reinstein DZ, Archer TJ, Gobbe M. The history of LASIK. J Refract Surg. 2012 Apr;28(4):291-8. doi: 10.3928/1081597X-20120229-01.
PubMed 22496438Soong 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.
PubMed 18930447Marino 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.
PubMed 28780779Ratkay-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.
PubMed 12701713
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Corneal Flap Thickness in Lasik Using Femtosecod Laser in Comparison to Moria Microkeratome
- ClinicalTrials.gov ID
- NCT03484468
- Acronym / sponsor ID
- femtosecond_vs_microkeratome
- Keywords
- lasik, flap_thickness, femtosecond, laser, moria, microkeratome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| femtosecond_laser | – | Device: anterior segment Ocular Coherence Tomographyparticipants had there lasik corneal flap creation using femtosecond laser |
| moria_microkeratome | – | Device: anterior segment Ocular Coherence Tomographyparticipants had there lasik corneal flap creation using moria microkeratome |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- population attending specialized eye centers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- A history of any systemic autoimmune disease.
- A history of diabetes.
- Other ophthalmic disorders.
- A history of ocular trauma and surgical history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior segment Ocular Coherence Tomographyanterior 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. | Device | femtosecond_laser, moria_microkeratome |
Primary outcome
corneal flap thickness
Time frame: 7 days
measuring the corneal flap thickness in nanometers postoperatively by anterior segment OCT
2 secondary outcomes
uncorrected visual acuity
Time frame: 7 days
best corrected visual acuity
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Results publication: PubMed 24790869Zhang 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.
- Results publicationF.A.Guarnieri(ed.), Introduction, Corneal Biomechanics and Refractive Surgery, © Springer Science+Business Media New York 2015 ; 1: 1
- Results publication: PubMed 19344821Solomon 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.
- Results publication: PubMed 11772601Sugar 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.
- Results publication: PubMed 19772267Hsu 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.
- Results publication: PubMed 18242446Ortiz 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.
- Results publication: PubMed 22496438Reinstein DZ, Archer TJ, Gobbe M. The history of LASIK. J Refract Surg. 2012 Apr;28(4):291-8. doi: 10.3928/1081597X-20120229-01.
- Results publication: PubMed 18930447Soong 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.
- Results publication: PubMed 28780779Marino 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.
- Results publication: PubMed 12701713Ratkay-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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GERGES F. YOUNAN, M.B.B.CH. principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Femtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SAMIR Y. SALIH, PHD (+201003304320, samir.abouelail@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal flap thickness (time frame: 7 days). 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 NCT03484468, which also lists 10 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 Mar 2018.