Clinical trial NCT04594603: Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
Official title: Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Retinopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital

Brief summary: To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA, a comparative study between healthy and diabetic patients

Detailed description: A prospective study of 30 patients with senile or complicated cataract scheduled to do phacoemulsification surgery in Tanta University Hospital

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.

Eligibility criteria: Inclusion Criteria:

* - Presence of a nuclear, cortical cataract or complicated cataract due to diabetic mellitus
* Intraocular pressure (IOP) of 21 mm Hg or lower
* Axial length (AL) between 20.0 mm and 25.0 mm.

Exclusion Criteria:

* Eyes with an AL longer than 25.0 mm or shorter than 20.0 mm,

  * 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

Primary outcomes:
measure: To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA
timeFrame: 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Garbeia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.