Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
NCT ID: NCT04594603
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2021-04-13
2024-12-30
Brief Summary
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Detailed Description
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Two groups will be divided:
1. Group (1): Cataract will no diabetic retinopathy
2. Group (2): Cataract associated with diabetic retinopathy.
All patients will be subject to Full ophthalmologic examination before the surgery. Imaging will include OCTA. OCTA will be performed using cirrus OCT (Zeiss, Inc., USA). High-quality 6 x 6 mm OCTA macular scans and 3 × 3-mm papillary scan with strong signal-noise ratio with adequate centration on the fovea and optic nerve head respectively will be selected.
Segmentation will be used to evaluate superficial and deep capillary retinal plexus projections in addition to the choriocapillaries. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) will be delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) will be segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL).
The vessel density metric from enface OCT angiogram will be used as an indicator of macular retinal and papillary perfusion. Vessel density (VD) analysis computes the percentage of area occupied by OCTA detected vasculature in a measured area. Choriocapillaries flow voids will be computed to assess choriocapillaries circulation.
The measurements of the OCTA, axial length, intraocular pressure will be obtained before the phacoemulsification surgery. Optical coherence tomography and IOP measurements will also be obtained 1 week after surgery.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group(1): Cataract with no diabetic retinopathy
Phacoemulsification for cataract
Phacoemulsification for removal of cataract
Group (2): Cataract associated with diabetic retinopathy
Phacoemulsification for cataract
Phacoemulsification for removal of cataract
Interventions
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Phacoemulsification for cataract
Phacoemulsification for removal of cataract
Eligibility Criteria
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Inclusion Criteria
* Intraocular pressure (IOP) of 21 mm Hg or lower
* Axial length (AL) between 20.0 mm and 25.0 mm.
Exclusion Criteria
* IOP higher than 21 mm Hg,
* History of ocular trauma or intraocular surgery, or any abnormal intraocular findings
* Poor OCT-A images because of severe cataracts or unstable fixation
* Any signs of intraoperative or postoperative complications
30 Years
70 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Dina Tadros
Lecturer of Ophthalmology, Tanta University, Egypt
Locations
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Tanta University Hospital
Tanta, El-Garbeia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Dina Tadros, MD
Role: primary
References
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Mirshahi A, Hohn F, Lorenz K, Hattenbach LO. Incidence of posterior vitreous detachment after cataract surgery. J Cataract Refract Surg. 2009 Jun;35(6):987-91. doi: 10.1016/j.jcrs.2009.02.016.
Ripandelli G, Coppe AM, Parisi V, Olzi D, Scassa C, Chiaravalloti A, Stirpe M. Posterior vitreous detachment and retinal detachment after cataract surgery. Ophthalmology. 2007 Apr;114(4):692-7. doi: 10.1016/j.ophtha.2006.08.045. Epub 2007 Jan 17.
Rossetti L, Autelitano A. Cystoid macular edema following cataract surgery. Curr Opin Ophthalmol. 2000 Feb;11(1):65-72. doi: 10.1097/00055735-200002000-00010.
Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557-634. No abstract available.
Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.
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.
Sorour OA, Sabrosa AS, Yasin Alibhai A, Arya M, Ishibazawa A, Witkin AJ, Baumal CR, Duker JS, Waheed NK. Optical coherence tomography angiography analysis of macular vessel density before and after anti-VEGF therapy in eyes with diabetic retinopathy. Int Ophthalmol. 2019 Oct;39(10):2361-2371. doi: 10.1007/s10792-019-01076-x. Epub 2019 May 22.
Other Identifiers
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34082/9/20
Identifier Type: -
Identifier Source: org_study_id