Changes of Macular Vasculature After Uncomplicated Phacoemulsification

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Diabetic Retinopathy

Clinical Trial Details

NCT number	NCT04594603
Study type	Observational [Patient Registry]
Source	Tanta University
Contact	Dina SM Tadros, MD
Phone	00201224093354
Email	dinasabry@rocketmail.com
Status	Recruiting
Phase
Start date	April 13, 2021
Completion date	December 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Changes of Macular Vasculature After Uncomplicated Phacoemulsification Surgery Using Optical Coherence Tomography Angiography

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms