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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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
phacoemulsification
cataract extraction

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Outcome

Type Measure Description Time frame Safety issue
Primary Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma electrophysiology and optical coherence tomography angiography changes before operation and 1st month, 3rd month post operative
Secondary Visual acuity and intra ocular pressure changes visual acuity and intraocular pressure changes before operation and 1st month, 3rd month post operative
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