AS-OCT Evaluation of Iridocorneal Angle of Patients of Angle Closure Glaucoma After Phacoemulsification

Sponsor

Minia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05332665

Collaborator

(none)

Enrollment

Location

10.6

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Angle-Closure	Device: AS-OCT Procedure: YAG laser PI

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

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 11, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Device: AS-OCT 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. Procedure: YAG laser PI 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
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	Device: AS-OCT 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. Procedure: YAG laser PI 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
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	Device: AS-OCT 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. Procedure: YAG laser PI 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

Arm

Intervention/Treatment

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

Device: AS-OCT

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.

Procedure: YAG laser PI

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

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

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

Device: AS-OCT

Procedure: YAG laser PI

Outcome Measures

Primary Outcome Measures

IOP [up to 6 months]
mmhg

Secondary Outcome Measures

Corneal endothelial count [up to 6 months]
CD per mm2

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with acute attack of angle closure glaucoma in one eye.
Patients fit for phacoemulsification

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	mohamed Mahmoud	Minia	El Minia	Egypt	61111

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: mohamed Salah, Minia faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Salah, Principal Investigator, Minia University

ClinicalTrials.gov Identifier:

NCT05332665

Other Study ID Numbers:

AS-OCT in ACG

First Posted:

Apr 18, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Angle-Closure

Study Results

No Results Posted as of Apr 18, 2022