Clinical Trials Directory

Trials / Unknown

UnknownNCT04594603

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

Status
Unknown
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Tanta University · Academic / Other
Sex
All
Age
30 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPhacoemulsification for cataractPhacoemulsification for removal of cataract

Timeline

Start date
2021-04-13
Primary completion
2021-12-30
Completion
2024-12-30
First posted
2020-10-20
Last updated
2023-12-05

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04594603. Inclusion in this directory is not an endorsement.