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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Osama A Sorour, MD contact

00201110813589

dr.osamasorour@gmail.com

ELSAYED A NASSAR, MD contact

00201222889473

SAYED.NASSAR@YAHOO.COM

Egypt1 site, 1 recruiting
  • Ophthalmology Department, Faculty of medicine, Tanta Univeristy

    Tanta, 31515

    Magdy Moussa, MD, magdymoussa60@gmail.com

    Recruiting

Other trials in Egypt

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.

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 groups in NCT04424069
Study groupRoleWhat they receive
LASIK groupActive comparatorPatients will do excimer laser LASIK operation for correction of myopia with flap creation by mechanical keratome
Receives: Procedure: Refractive surgery
SMILE groupActive comparatorPatients will do Femtosecond laser assisted corneal refractive surgery for correction of myopia
Receives: Procedure: Refractive surgery
Photorefractive keratectomy groupActive comparatorPatients that will undergo photorefractive keratectomy for correction of myopia
Receives: Procedure: Refractive surgery
Refractive lens exchangeActive comparatorInclude eyes that will undergo refractive lens exchange
Receives: Procedure: Refractive surgery
Control groupNo interventionMyopic control eyes with no surgical intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted9 Jun 2020
  2. Study start1 Mar 2020
  3. Primary completionOct 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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 30817826
  • 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.

    PubMed 31236353
  • 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.

    PubMed 21912236
  • 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.

    PubMed 16565009
  • 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.

    PubMed 14709290
  • 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.

    PubMed 29436208

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.

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