Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05871034 |
Other study ID # |
SAHASSAN |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 15, 2023 |
Est. completion date |
December 1, 2024 |
Study information
Verified date |
May 2023 |
Source |
Sohag University |
Contact |
shorouq abdelrahman |
Phone |
01016685915 |
Email |
shorouqabdelrahman2015[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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)