Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT05871034
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electroretinogram and Retinal Vascular Changes After Cataract Surgery
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: