Glaucoma, Angle-ClosureNCT05332665
AS-OCT Evaluation of Iridocorneal Angle of Patients of Angle Closure Glaucoma After Phacoemulsification
An observational study of Glaucoma, Angle-Closure, run by Minia University at 1 site in Egypt.
Trial summary
Evaluation of the effect of phacoemulsification and YAG Laser peripheral iridotomy on the anterior chamber angle anatomic parameters in PACG eyes, using anterior segment optical coherence tomography (SS ASOCT) device Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- AS-OCT and YAG laser PI
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2022to Dec 2022
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with acute attack of ACG with phacoemulsification in this eye with YAG laser PI in the other eye
Who may be able to join
- patients with acute attack of angle closure glaucoma in one eye.
- Patients fit for phacoemulsification
Who cannot join
- 1- Patients with history of any intraocular surgery. 2- Patients with history of refractive surgery. 3- Patients with diabetic retinal vasculopathy or retinal detachment. 4- Patients with chronic angle closure glaucoma, open angle glaucoma or 2ry glaucoma
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
mohamed Mahmoud
Minya, Minya Governorate, 61111
mohamed Mahmoud
About this study
Official title: Anterior Segment Optical Coherence Tomography Evaluation of Iridocorneal Angle of Patients of Angle Closure Glaucoma After Phacoemulsification and YAG Laser Iridotomy, Comparative Study
Evaluation of the effect of phacoemulsification and YAG Laser peripheral iridotomy on the anterior chamber angle anatomic parameters in PACG eyes, using anterior segment optical coherence tomography (SS ASOCT) device
Read the detailed description
The recent treatment of ACG is phacoemulsification in patients of acute attack with YAG laser iridotomy in the other eye.
The AS-OCT will be used for evaluation of the angle of the anterior chamber parameters in both eyes after phacoemulsification and YAG laser peripheral iridotomy.
Follow up of AS-OCT will be done 1,3,6 months after surgery and we will compare results in each eye and between both eyes.
.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- AS-OCT, YAG laser PI
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS-OCTDevice
Anterior segment optical coherence tomography (AS OCT) is an imaging device that can acquire an anterior segment image using a noncontact method with the patient in a sitting position. This device provides reproducible and quantitative measurements of the AC angle and other anterior segment parameters.
YAG laser PIProcedure or surgery
medical procedure which uses a laser device to create a hole in the iris, thereby allowing aqueous humor to traverse directly from the posterior to the anterior chamber and, consequently, relieve a pupillary block
| Study group | Role | What they receive |
|---|---|---|
| Angle opening distance (AOD) | The AOD measured as perpendicular distance between anterior iris surface and point at trabecular meshwork at 500 μm anterior to the scleral spur Receives: Device: AS-OCT; Procedure: YAG laser PI | |
| Trabecular iris space area (TISA) 500 | TISA 500 was measured as an area bounded anteriorly by the AOD 500, posteriorly by a line drawn from the scleral spur perpendicular to the plane of the inner scleral wall to the opposing iris, superiorly by the inner corneoscleral wall, and inferiorly by the iris surface Receives: Device: AS-OCT; Procedure: YAG laser PI | |
| Anterior chamber depth (ACD) | The ACD was measured as the perpendicular distance from the corneal endothelium at the corneal apex to the anterior lens surface Receives: Device: AS-OCT; Procedure: YAG laser PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
mmhg
Measured: up to 6 months
Secondary outcomes (1)
Corneal endothelial count
CD per mm2
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start11 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Minia University
- Investigators
- mohamed Salah, Principal investigator, Minia faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332665
- Sponsor's protocol ID
- AS-OCT in ACG
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not decided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Optical Coherence Tomography Evaluation of Iridocorneal Angle of Patients of Angle Closure Glaucoma After Phacoemulsification and YAG Laser Iridotomy, Comparative Study
- ClinicalTrials.gov ID
- NCT05332665
- Acronym / sponsor ID
- AS-OCT in ACG
- Conditions
- Glaucoma, Angle-Closure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Apr 2022 (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.
Evaluation of the effect of phacoemulsification and YAG Laser peripheral iridotomy on the anterior chamber angle anatomic parameters in PACG eyes, using anterior segment optical coherence tomography (SS ASOCT) device
Detailed description
The recent treatment of ACG is phacoemulsification in patients of acute attack with YAG laser iridotomy in the other eye.
The AS-OCT will be used for evaluation of the angle of the anterior chamber parameters in both eyes after phacoemulsification and YAG laser peripheral iridotomy.
Follow up of AS-OCT will be done 1,3,6 months after surgery and we will compare results in each eye and between both eyes.
.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Angle opening distance (AOD) | – | Device: AS-OCT, Procedure: YAG laser PIThe AOD measured as perpendicular distance between anterior iris surface and point at trabecular meshwork at 500 μm anterior to the scleral spur |
| Trabecular iris space area (TISA) 500 | – | Device: AS-OCT, Procedure: YAG laser PITISA 500 was measured as an area bounded anteriorly by the AOD 500, posteriorly by a line drawn from the scleral spur perpendicular to the plane of the inner scleral wall to the opposing iris, superiorly by the inner corneoscleral wall, and inferiorly by the iris surface |
| Anterior chamber depth (ACD) | – | Device: AS-OCT, Procedure: YAG laser PIThe ACD was measured as the perpendicular distance from the corneal endothelium at the corneal apex to the anterior lens surface |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with acute attack of ACG with phacoemulsification in this eye with YAG laser PI in the other eye
Key inclusion criteria (2 listed)
- patients with acute attack of angle closure glaucoma in one eye.
- Patients fit for phacoemulsification
Key exclusion criteria (1 listed)
- 1- Patients with history of any intraocular surgery. 2- Patients with history of refractive surgery. 3- Patients with diabetic retinal vasculopathy or retinal detachment. 4- Patients with chronic angle closure glaucoma, open angle glaucoma or 2ry glaucoma
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 |
|---|---|---|
| AS-OCTAnterior segment optical coherence tomography (AS OCT) is an imaging device that can acquire an anterior segment image using a noncontact method with the patient in a sitting position. This device provides reproducible and quantitative measurements of the AC angle and other anterior segment parameters. | Device | Angle opening distance (AOD), Anterior chamber depth (ACD), Trabecular iris space area (TISA) 500 |
| YAG laser PImedical procedure which uses a laser device to create a hole in the iris, thereby allowing aqueous humor to traverse directly from the posterior to the anterior chamber and, consequently, relieve a pupillary block | Procedure or surgery | Angle opening distance (AOD), Anterior chamber depth (ACD), Trabecular iris space area (TISA) 500 |
Primary outcome
IOP
Time frame: up to 6 months
mmhg
1 secondary outcome
Corneal endothelial count
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No. Not decided
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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.
mohamed Salah principal investigator
Minia faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Angle-Closure, run by Minia University at 1 site in Egypt.
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 1 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 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 mohamed Salah (01003321802, drmsalah1982@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: up to 6 months). 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 18 Apr 2022.