Electroretinogram and Retinal Vascular Changes After Cataract Surgery

Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Procedure: phacoemulsification

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)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shorouq abdelrahman; Phone Number: 01016685915; Email: shorouqabdelrahman2015@gmail.com
• Study Contact Backup: Name: alaa mahmoud; Phone Number: 01060422011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Control group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery	Procedure: phacoemulsification; cataract extraction
Other: Open Angle glaucoma group; patients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery	Procedure: phacoemulsification; cataract extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma	electrophysiology and optical coherence tomography angiography changes	before operation and 1st month, 3rd month post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity and intra ocular pressure changes	visual acuity and intraocular pressure changes	before operation and 1st month, 3rd month post operative

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: shorouq abdelrahman, Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2023
• Primary Completion (Anticipated): May 15, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 13, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: OCTA: optical coherence tomography angiography; ERG: electroretinogram; POAG: primary open Angle glaucoma; V/A: visual acuity; IOP: intra ocular pressure
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: SAHASSAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No