Clinical trial NCT05871034: Electroretinogram and Retinal Vascular Changes After Cataract Surgery
Official title: Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: OCTA: optical coherence tomography angiography
ERG: electroretinogram
POAG: primary open Angle glaucoma
V/A: visual acuity
IOP: intra ocular pressure
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare electrophysiological and Optical coherence tomography angiography of optic disc and macula changes after uneventful phacoemulsification between normal and cataractus patients with primary open angle glaucoma.

Detailed description: * Study design: A prospective, non randomized, interventional, comparative study, control based study.
* Location: Ophthalmology department, Sohag university hospital. In this prospective study, aiming to investigate Optical coherence tomography angiography and electrophysiological changes after cataract surgery in normal and patients with POAG with cataract 1 day before operation, 1 week and 3 months postoperatively.
* Methodology The study will include 50 patients with primary open angle glaucoma associated with cataract and 50 patients have cataract without glaucoma.

Preoperative and postoperative evaluation:

All patients will be subjected to the following:

* History taking including age, gender, family history, systemic diseases, previous medications or ophthalmic surgery.
* Detailed ophthalmological examination including: Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA) by Snellen's fraction and converted into logarithm of the minimal angle of resolution LogMAR, refraction, keratometry, slit lamp biomicroscopy for anterior segment, IOP measurement by applanation tonometer, and posterior segment (Fundus) examination.
* Examination of the angle of anterior chamber by goniolens.
* OCTA disc and macula
* Pattern ERG and multifocal ERG

Surgical techniques:

Patients will be subdivided into two groups:

Group (A): normal Patients will undergo standard phacoemulsification surgery. Group (B): Patients with POAG will undergo standard phacoemulsification surgery.

\* phaco technology by using (WHITESTAR SIGNATURE PRO, Abbott, USA)

* OCT angiography will be done by (Optovue, Inc., Fremont, California, USA).
* Electrophysiology will be done by (Roland consult Retimap, Germany)

Eligibility criteria: Inclusion Criteria:

* Patients aged: 45-65 years old with cataract density doesn't interfere with Pre-operative imaging (N1-N2).
* Patients with primary open angle diagnosed for at least 2 years with glaucoma treatment associated with cataract (N1-N2).

Exclusion criteria:

s▪ patient with PACG.

* Previous intraocular surgery.
* Associated ocular or intra ocular inflammation
* Previous history of eye trauma.
* Associated intraocular pathology

Primary outcomes:
measure: Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma
timeFrame: before operation and 1st month, 3rd month post operative
Secondary outcomes:
measure: Visual acuity and intra ocular pressure changes
timeFrame: before operation and 1st month, 3rd month post operative
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: shorouq abdelrahman
role: PRINCIPAL_INVESTIGATOR
References: