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Electroretinogram and Retinal Vascular Changes After Cataract Surgery

Primary Purpose

Primary Open Angle Glaucoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phacoemulsification
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Primary Open Angle Glaucoma focused on measuring OCTA: optical coherence tomography angiography, ERG: electroretinogram, POAG: primary open Angle glaucoma, V/A: visual acuity, IOP: intra ocular pressure

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Control group

    Open Angle glaucoma group

    Arm Description

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

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

    Outcomes

    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
    electrophysiology and optical coherence tomography angiography changes

    Secondary Outcome Measures

    Visual acuity and intra ocular pressure changes
    visual acuity and intraocular pressure changes

    Full Information

    First Posted
    May 4, 2023
    Last Updated
    May 13, 2023
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05871034
    Brief Title
    Electroretinogram and Retinal Vascular Changes After Cataract Surgery
    Official Title
    Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. 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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Open Angle Glaucoma
    Keywords
    OCTA: optical coherence tomography angiography, ERG: electroretinogram, POAG: primary open Angle glaucoma, V/A: visual acuity, IOP: intra ocular pressure

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Control group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery
    Arm Title
    Open Angle glaucoma group
    Arm Type
    Other
    Arm Description
    patients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    phacoemulsification
    Intervention Description
    cataract extraction
    Primary Outcome Measure Information:
    Title
    Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma
    Description
    electrophysiology and optical coherence tomography angiography changes
    Time Frame
    before operation and 1st month, 3rd month post operative
    Secondary Outcome Measure Information:
    Title
    Visual acuity and intra ocular pressure changes
    Description
    visual acuity and intraocular pressure changes
    Time Frame
    before operation and 1st month, 3rd month post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shorouq abdelrahman
    Phone
    01016685915
    Email
    shorouqabdelrahman2015@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    alaa mahmoud
    Phone
    01060422011
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    shorouq abdelrahman
    Organizational Affiliation
    Sohag University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Electroretinogram and Retinal Vascular Changes After Cataract Surgery

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