Electroretinogram and Retinal Vascular Changes After Cataract Surgery

NCT ID: NCT05871034

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-12-01

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)

Conditions

Primary Open Angle Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

Control group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery

Group Type: OTHER

phacoemulsification

Intervention Type: PROCEDURE

cataract extraction

Open Angle glaucoma group

patients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery

Group Type: OTHER

phacoemulsification

Intervention Type: PROCEDURE

cataract extraction

Interventions

phacoemulsification

cataract extraction

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Shorouq Abdelrahman Hassan

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

shorouq abdelrahman

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Central Contacts

shorouq abdelrahman

Role: CONTACT

shorouqabdelrahman2015@gmail.com

01016685915

alaa mahmoud

Role: CONTACT

01060422011

Other Identifiers

SAHASSAN

Identifier Type: -

Identifier Source: org_study_id