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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04594603
Enrollment
30
Registered
2020-10-20
Start date
2021-04-13
Completion date
2024-12-30
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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.

Interventions

OTHERPhacoemulsification for cataract

Phacoemulsification for removal of cataract

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To record the vascular changes that may be present in the macular after uncomplicated phacoemulsification surgery by using OCTA1 week after surgery

Countries

Egypt

Contacts

Primary ContactDina SM Tadros, MD
dinasabry@rocketmail.com00201224093354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026