Electroretinogram and Retinal Vascular Changes After Cataract Surgery

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05871034

Collaborator

(none)

100

Enrollment

Arms

18.6

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma	Procedure: phacoemulsification	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Visual acuity and intra ocular pressure changes [before operation and 1st month, 3rd month post operative]
visual acuity and intraocular pressure changes

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).