OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes
Optical Coherence Tomography Angiography Analysis of Macular and Papillary Perfusion After Variable Refractive Surgery Methods in Myopic Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 6, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 28, 2020
July 1, 2020
7 months
June 6, 2020
July 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Vessel density from enface OCT angiogram
VD analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area
6 months
Study Arms (5)
LASIK group
ACTIVE COMPARATORPatients will do excimer laser LASIK operation for correction of myopia with flap creation by mechanical keratome
SMILE group
ACTIVE COMPARATORPatients will do Femtosecond laser assisted corneal refractive surgery for correction of myopia
Photorefractive keratectomy group
ACTIVE COMPARATORPatients that will undergo photorefractive keratectomy for correction of myopia
Refractive lens exchange
ACTIVE COMPARATORInclude eyes that will undergo refractive lens exchange
Control group
NO INTERVENTIONMyopic control eyes with no surgical intervention
Interventions
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
Eligibility Criteria
You may qualify if:
- Age: between 20 - 35 years
- Patients: who are seeking and fit for refractive surgery
- Spherical equivalent refractive error: between (-2 to -9 D)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Ophthalmology Department, Faculty of medicine, Tanta Univeristy
Tanta, 31515, Egypt
Related Publications (6)
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.
PMID: 30817826BACKGROUNDRenones 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.
PMID: 31236353BACKGROUNDVetter 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.
PMID: 21912236BACKGROUNDKhng 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.
PMID: 16565009BACKGROUNDWhitson 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.
PMID: 14709290BACKGROUNDOr 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.
PMID: 29436208BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rauf A gaber, MD
Tanta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Retina consultant & the principal investigator
Study Record Dates
First Submitted
June 6, 2020
First Posted
June 9, 2020
Study Start
March 1, 2020
Primary Completion
October 1, 2020
Study Completion
December 1, 2020
Last Updated
July 28, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share