Primary Open Angle GlaucomaNCT05871034
Electroretinogram and Retinal Vascular Changes After Cataract Surgery
A study testing phacoemulsification in people with Primary Open Angle Glaucoma, run by Sohag University.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- s▪ patient with PACG.
- Previous intraocular surgery.
- Associated ocular or intra ocular inflammation
- Previous history of eye trauma.
- Associated intraocular pathology
Trial locations and contacts
No sites are listed yet.
alaa mahmoud contact
About this study
Official title: Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification
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.
Read the 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)
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- phacoemulsification
- Keywords
- OCTA: optical coherence tomography angiography, ERG: electroretinogram, POAG: primary open Angle glaucoma, V/A: visual acuity, IOP: intra ocular pressure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsificationProcedure or surgery
cataract extraction
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Control group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery Receives: Procedure: phacoemulsification |
| Open Angle glaucoma group | Other | patients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery Receives: Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before operation and 1st month, 3rd month post operative
Secondary outcomes (1)
Visual acuity and intra ocular pressure changes
visual acuity and intraocular pressure changes
Measured: before operation and 1st month, 3rd month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 May 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorouq Abdelrahman Hassan, Sohag University
- Investigators
- shorouq abdelrahman, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871034
- Sponsor's protocol ID
- SAHASSAN
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Electrophysiology and Optical Coherence Tomography Angiography in Primary Open Angle Glaucoma After Phacoemulsification
- ClinicalTrials.gov ID
- NCT05871034
- Acronym / sponsor ID
- SAHASSAN
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: phacoemulsificationControl group who have cataract without Open Angle glaucoma Will under go phacoemulsification cataract surgery |
| Open Angle glaucoma group | Other | Procedure: phacoemulsificationpatients who have cataract and Open Angle glaucoma Will undergo phacoemulsification cataract surgery |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- s▪ patient with PACG.
- Previous intraocular surgery.
- Associated ocular or intra ocular inflammation
- Previous history of eye trauma.
- Associated intraocular pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacoemulsificationcataract extraction | Procedure or surgery | Control group, Open Angle glaucoma group |
Primary outcome
Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma
Time frame: before operation and 1st month, 3rd month post operative
electrophysiology and optical coherence tomography angiography changes
1 secondary outcome
Visual acuity and intra ocular pressure changes
Time frame: before operation and 1st month, 3rd month post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Primary Open Angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 2
Nicotinamide for Retinal Protection in Primary Open-Angle Glaucoma (NADIR Trial)
Glaucoma, Open-angle, Primary Open Angle Glaucoma (POAG)
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alaa mahmoud contact
shorouq abdelrahman principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing phacoemulsification in people with Primary Open Angle Glaucoma, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shorouq abdelrahman (01016685915, shorouqabdelrahman2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern and multifocal electroretinogram and Optical coherence tomography angiography of optic disc and macula changes after phacoemulsification in primary open angle glaucoma (time frame: before operation and 1st month, 3rd month post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.