NCT05871034

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 4, 2023

Last Update Submit

May 13, 2023

Conditions

Keywords

OCTA: optical coherence tomography angiographyERG: electroretinogramPOAG: primary open Angle glaucomaV/A: visual acuityIOP: intra ocular pressure

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Visual acuity and intra ocular pressure changes

    before operation and 1st month, 3rd month post operative

Study Arms (2)

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

cataract extraction

Control groupOpen Angle glaucoma group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • s▪ patient with PACG.
  • Previous intraocular surgery.
  • Associated ocular or intra ocular inflammation
  • Previous history of eye trauma.
  • Associated intraocular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • shorouq abdelrahman

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

alaa mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 23, 2023

Study Start

May 15, 2023

Primary Completion

May 15, 2024

Study Completion

December 1, 2024

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share