OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes
Primary Purpose
Myopia, Perfusion; Complications
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Refractive surgery
Sponsored by
About this trial
This is an interventional screening trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Age: between 20 - 35 years
- Patients: who are seeking and fit for refractive surgery
- Spherical equivalent refractive error: between (-2 to -9 D)
Exclusion Criteria:
- Maculopathies (hereditary or acquired)
- optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.)
- optic neuropathies (demyelinating, infectious, ischemic, etc.)
- adjusted IOP for central corneal thickness more than 21 mmHg
- surgery-induced corneal edema
- dense cataracts that can disrupt images
- systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.)
- any previous ocular surgery,
- patients with bad quality images or complicated surgeries will be excluded
Sites / Locations
- Ophthalmology Department, Faculty of medicine, Tanta UniveristyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
LASIK group
SMILE group
Photorefractive keratectomy group
Refractive lens exchange
Control group
Arm Description
Patients will do excimer laser LASIK operation for correction of myopia with flap creation by mechanical keratome
Patients will do Femtosecond laser assisted corneal refractive surgery for correction of myopia
Patients that will undergo photorefractive keratectomy for correction of myopia
Include eyes that will undergo refractive lens exchange
Myopic control eyes with no surgical intervention
Outcomes
Primary Outcome Measures
Vessel density from enface OCT angiogram
VD analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424069
Brief Title
OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes
Official Title
Optical Coherence Tomography Angiography Analysis of Macular and Papillary Perfusion After Variable Refractive Surgery Methods in Myopic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Refractive surgery for correction of myopia is very common nowadays. However, various refractive techniques may be associated with increase in the IOP, especially during flap creation. It is assumed that marked intraoperative IOP increase lead to macular and optic disc head circulation compromise. The purpose of this study is to assess the change of macular and papillary perfusion, using optical coherence tomography angiography (OCTA) imaging of the macula and optic disc of myopic patients before and after various refractive surgery methods.
Detailed Description
Myopia is the most prevalent ocular disorder in children worldwide, and one of the major causes of visual deterioration in all age groups. Highest prevalence rates are in East Asian countries (affecting up to 83% of Singaporean teenagers), however, it is very common in all other countries. While mild to moderate myopia usually stabilizes within the third decade, pathological myopia is associated with progressive globe elongation, and development of various macular complications including; foveoschisis, choroidal neovascularization (CNV), myopic macular hole, and myopic vitreomacular traction (VMT).
Refractive surgery has become popular for correcting ametropia including myopia. Most commonly used refractive procedures include corneal refractive surgeries especially laser in-situ keratomileusis (LASIK), and Photorefractive keratectomy (PRK), Phakic Intraocular Lenses (Phakic IOLs) and refractive lens exchange.
In LASIK, the creation of a corneal lamellar flap requires placement of a suction ring on the anterior segment of the eye, which transiently elevates the intraocular pressure (IOP) to levels exceeding 65 mmHg. Experimental studies in animal eyes have found that the IOP can increase to between 80 mmHg and 360 mmHg during this vacuum phase and lamellar cut with the microkeratome. Recent advances utilizing the femtosecond laser may serve as an alternative to the mechanical microkeratome, with a low-pressure suction ring. In studies using porcine eyes, the IOP during the suctioning or laser application phase reached a maximum of 135 mmHg using the femtosecond laser, lower than pressures reached with a traditional microkeratome, but for a longer duration of time. Similarly in refractive lens procedures, intraoperative IOP was found to exceed 60 mmHg.
Intraocular pressure elevation during refractive procedures may cause a reduction in the perfusion of the retina and optic nerve head, posterior displacement of the lamina cribrosa, and a decline in ocular perfusion pressure of the posterior ciliary arteries. Although this IOP elevation is temporary, the potential for ischemic or pressure-induced damage to the optic nerve head and the retinal nerve fiber layer exists.
Optical coherence tomography angiography (OCTA) is a recent noninvasive imaging technique that allows for volumetric visualization of eye vasculature. OCTA has shown promise in better elucidating the pathophysiology of several retinal vascular diseases. Swept-source OCTA uses long wavelength ̰ 1,050nm, which can penetrate through deeper layers of the eye and can traverse opacities of media such as cataracts, hemorrhages and vitreous opacities [6]. Optical coherence tomographic angiograms can further be manually or automatically segmented with preprogrammed software to highlight individual layers of the retina, optic nerve head choriocapillaris, and choroid. The user can either analyze en face images extending from the inner limiting membrane to choroid or use automated views to locate a vascular or structural lesion within the retina.
The purpose of this study is to assess the change of macular and papillary perfusion, using optical coherence tomography angiography (OCTA) imaging of the macula and optic disc of myopic patients subject to various refractive surgery methods. We will compare between these methods to evaluate which one is associated with least adverse effect on ocular perfusion. To date no such evaluation has been done using OCTA, because of relatively recent onset of this technology. Traditional imaging methods such as color fundus photography and fluorescein angiography have limited resolution for retinal vasculature that mad such evaluation in the past using these methods not feasible, however, OCTA is very promising for the proper analysis of changes in the ocular perfusion. Results of this study will have significant clinical and practical implications and may change the approach for surgical correction of such patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Perfusion; Complications
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LASIK group
Arm Type
Active Comparator
Arm Description
Patients will do excimer laser LASIK operation for correction of myopia with flap creation by mechanical keratome
Arm Title
SMILE group
Arm Type
Active Comparator
Arm Description
Patients will do Femtosecond laser assisted corneal refractive surgery for correction of myopia
Arm Title
Photorefractive keratectomy group
Arm Type
Active Comparator
Arm Description
Patients that will undergo photorefractive keratectomy for correction of myopia
Arm Title
Refractive lens exchange
Arm Type
Active Comparator
Arm Description
Include eyes that will undergo refractive lens exchange
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Myopic control eyes with no surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Refractive surgery
Intervention Description
Myopic patients seeking refractive surgery will be assigned to the study groups to assess the change in myopic and papillary perfusion in these different prodecures
Primary Outcome Measure Information:
Title
Vessel density from enface OCT angiogram
Description
VD analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: between 20 - 35 years
Patients: who are seeking and fit for refractive surgery
Spherical equivalent refractive error: between (-2 to -9 D)
Exclusion Criteria:
Maculopathies (hereditary or acquired)
optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.)
optic neuropathies (demyelinating, infectious, ischemic, etc.)
adjusted IOP for central corneal thickness more than 21 mmHg
surgery-induced corneal edema
dense cataracts that can disrupt images
systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.)
any previous ocular surgery,
patients with bad quality images or complicated surgeries will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama A Sorour, MD
Phone
00201110813589
Email
dr.osamasorour@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ELSAYED A NASSAR, MD
Phone
00201222889473
Email
SAYED.NASSAR@YAHOO.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rauf A gaber, MD
Organizational Affiliation
Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Ophthalmology Department, Faculty of medicine, Tanta Univeristy
City
Tanta
ZIP/Postal Code
31515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy Moussa, MD
Email
magdymoussa60@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30817826
Citation
Flitcroft DI, He M, Jonas JB, Jong M, Naidoo K, Ohno-Matsui K, Rahi J, Resnikoff S, Vitale S, Yannuzzi L. IMI - Defining and Classifying Myopia: A Proposed Set of Standards for Clinical and Epidemiologic Studies. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M20-M30. doi: 10.1167/iovs.18-25957.
Results Reference
background
PubMed Identifier
31236353
Citation
Renones de Abajo J, Estevez Jorge B, Gonzalez Martin JM, Carreras Diaz H, Loro Ferrer JF, Anton Lopez A. Effect of femtosecond laser-assisted lens surgery on the optic nerve head and the macula. Int J Ophthalmol. 2019 Jun 18;12(6):961-966. doi: 10.18240/ijo.2019.06.13. eCollection 2019.
Results Reference
background
PubMed Identifier
21912236
Citation
Vetter JM, Schirra A, Garcia-Bardon D, Lorenz K, Weingartner WE, Sekundo W. Comparison of intraocular pressure during corneal flap preparation between a femtosecond laser and a mechanical microkeratome in porcine eyes. Cornea. 2011 Oct;30(10):1150-4. doi: 10.1097/ICO.0b013e318212110a.
Results Reference
background
PubMed Identifier
16565009
Citation
Khng C, Packer M, Fine IH, Hoffman RS, Moreira FB. Intraocular pressure during phacoemulsification. J Cataract Refract Surg. 2006 Feb;32(2):301-8. doi: 10.1016/j.jcrs.2005.08.062.
Results Reference
background
PubMed Identifier
14709290
Citation
Whitson JT, McCulley JP, Cavanagh HD, Song J, Bowman RW, Hertzog L. Effect of laser in situ keratomileusis on optic nerve head topography and retinal nerve fiber layer thickness. J Cataract Refract Surg. 2003 Dec;29(12):2302-5. doi: 10.1016/s0886-3350(03)00466-8.
Results Reference
background
PubMed Identifier
29436208
Citation
Or C, Sabrosa AS, Sorour O, Arya M, Waheed N. Use of OCTA, FA, and Ultra-Widefield Imaging in Quantifying Retinal Ischemia: A Review. Asia Pac J Ophthalmol (Phila). 2018 Jan-Feb;7(1):46-51. doi: 10.22608/APO.201812. Epub 2018 Feb 13.
Results Reference
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OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes
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