Electroretinogram and Retinal Vascular Changes After Cata... | NCT05871034

Studies
Electroretinogram and Retinal Vascular Changes After Cataract Surgery

NCT05871034

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

May 23, 2023Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Primary Open Angle Glaucoma

Interventions

phacoemulsification

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Estimated

Primary Completion Date

May 15, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

May 4, 2023

First Submission Date that Met QC Criteria

May 13, 2023

First Posted Date

May 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2023

Last Update Posted Date

May 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shorouq Abdelrahman Hassan, Assistant lecturer, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Other	Control group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery	Procedure: phacoemulsification
Open Angle glaucoma group	Other	patients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery	Procedure: phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phacoemulsification	Procedure	cataract extraction	Control group Open Angle glaucoma group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Visual acuity and intra ocular pressure changes	visual acuity and intraocular pressure changes	before operation and 1st month, 3rd month post operative

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shorouq abdelrahman	Contact	01016685915		shorouqabdelrahman2015@gmail.com
alaa mahmoud	Contact	01060422011

Overall Officials

Name	Affiliation	Role
shorouq abdelrahman	Sohag University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Sep 23, 2025
Reset	Oct 10, 2025

Submission Tracking

Estimated Results First Submitted Date

Sep 23, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 23, 2025			Oct 10, 2025

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided