MyopiaNCT04424069
OCTA Analysis of Macular and Papillary Perfusion After Refractive Surgery in Myopes
A study testing Refractive surgery in people with Myopia and Perfusion; Complications, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Myopia, Perfusion; Complications
- What is being tested?
- Refractive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to Dec 2020
- Phase
- Interventional
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: between 20 - 35 years
- Patients: who are seeking and fit for refractive surgery
- Spherical equivalent refractive error: between (-2 to -9 D)
Who cannot join
- 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
Show all 9Show fewer
- systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.)
- any previous ocular surgery,
- patients with bad quality images or complicated surgeries will be excluded
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ophthalmology Department, Faculty of medicine, Tanta Univeristy
Tanta, 31515
Magdy Moussa, MD, magdymoussa60@gmail.com
About this study
Official title: Optical Coherence Tomography Angiography Analysis of Macular and Papillary Perfusion After Variable Refractive Surgery Methods in Myopic Patients
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.
Read the 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.
- Conditions
- Myopia, Perfusion; Complications
- Being tested
- Refractive surgery
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refractive surgeryProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| LASIK group | Active comparator | Patients will do excimer laser LASIK operation for correction of myopia with flap creation by mechanical keratome Receives: Procedure: Refractive surgery |
| SMILE group | Active comparator | Patients will do Femtosecond laser assisted corneal refractive surgery for correction of myopia Receives: Procedure: Refractive surgery |
| Photorefractive keratectomy group | Active comparator | Patients that will undergo photorefractive keratectomy for correction of myopia Receives: Procedure: Refractive surgery |
| Refractive lens exchange | Active comparator | Include eyes that will undergo refractive lens exchange Receives: Procedure: Refractive surgery |
| Control group | No intervention | Myopic control eyes with no surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel density from enface OCT angiogram
VD analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Mar 2020
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Abdelfattah Sorour, Tanta University
- Investigators
- Rauf A gaber, MD, Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424069
- Sponsor's protocol ID
- 33553/12/19
- Status last verified
- Jul 2020
- First submitted
- 6 Jun 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30817826Renones 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.
PubMed 31236353Vetter 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.
PubMed 21912236Khng 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.
PubMed 16565009Whitson 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.
PubMed 14709290Or 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.
PubMed 29436208
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Analysis of Macular and Papillary Perfusion After Variable Refractive Surgery Methods in Myopic Patients
- ClinicalTrials.gov ID
- NCT04424069
- Acronym / sponsor ID
- 33553/12/19
- Conditions
- Myopia, Perfusion; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LASIK group | Active comparator | Procedure: Refractive surgeryPatients will do excimer laser LASIK operation for correction of myopia with flap creation by mechanical keratome |
| SMILE group | Active comparator | Procedure: Refractive surgeryPatients will do Femtosecond laser assisted corneal refractive surgery for correction of myopia |
| Photorefractive keratectomy group | Active comparator | Procedure: Refractive surgeryPatients that will undergo photorefractive keratectomy for correction of myopia |
| Refractive lens exchange | Active comparator | Procedure: Refractive surgeryInclude eyes that will undergo refractive lens exchange |
| Control group | No intervention | –Myopic control eyes with no surgical intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: between 20 - 35 years
- Patients: who are seeking and fit for refractive surgery
- Spherical equivalent refractive error: between (-2 to -9 D)
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Refractive surgeryMyopic patients seeking refractive surgery will be assigned to the study groups to assess the change in myopic and papillary perfusion in these different prodecures | Procedure or surgery | LASIK group, Photorefractive keratectomy group, Refractive lens exchange, SMILE group |
Primary outcome
Vessel density from enface OCT angiogram
Time frame: 6 months
VD analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 30817826Flitcroft 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.
- Background: PubMed 31236353Renones 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.
- Background: PubMed 21912236Vetter 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.
- Background: PubMed 16565009Khng 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.
- Background: PubMed 14709290Whitson 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.
- Background: PubMed 29436208Or 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.
- Individual participant dataSharing planned: No
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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.
Rauf A gaber, MD study chair
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refractive surgery in people with Myopia and Perfusion; Complications, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 9 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Osama A Sorour, MD (00201110813589, dr.osamasorour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel density from enface OCT angiogram (time frame: 6 months). 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 NCT04424069, which also lists 6 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 28 Jul 2020.