Electroretinogram and Retinal Vascular Changes After Cataract Surgery

Sohag University

Status: Not yet enrolling

Conditions: Primary Open Angle Glaucoma

Treatments: Procedure: phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT05871034

SAHASSAN

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

Other group

Description:

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

Treatment:

Procedure: phacoemulsification

Open Angle glaucoma group

Other group

Description:

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

Treatment:

Procedure: phacoemulsification