Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma

NCT06000176 | Completed FDA Device

• 1 other identifier: M557
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA).

Conditions

Glaucoma,Primary Open-Angle ,Primary Angle Closure

Outcome Measures

Primary Outcomes (1)

• OCTA macula and ONH

  macular 6\*6,3\*3 and peripapillary vessel density

  We will recruit patient that include the inclusion criteria from april2022 to july 2023

Study Arms (1)

interventional details : diagnostic test OCTA macula and ONH

interventional details : diagnostic test OCTA macula and ONH in the 3 groups

Device: Optical coherence tomography angiography

Interventions

Optical coherence tomography angiography DEVICE

diagnostic test OCTA macula and ONH

interventional details : diagnostic test OCTA macula and ONH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary open angle ,primary angle closure glaucoma and control patients

You may qualify if:

• Age ≥ 18 years old.
• Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which \> 180˚ of trabecular meshwork cannot be seen , IOP\>21, Optic disc and RNFL damage due to glaucoma
• Diagnosed POAG patient: open anterior chamber angle ,IOP\>21 ,Optic disc and RNFL damage due to glaucoma
• Healthy patient: normal anterior chamber, open angle and normal fundus.

You may not qualify if:

• History of other causes of optic neuropathy.
• History of systemic diseases. (HTN, DM, Cardiac).
• Previous ocular surgeries or Laser iridotomy.
• Poor quality of OCTA image less than 4/10.
• Refractive errors \> 6 diopters sphere, \>3 diopter cylinder
• Poor cooperation or fixation with the OCTA examination.
• Secondary causes of glaucoma
• Media opacity that interfere with quality of image (dense cataract,corneal opacity,…)
• Previous acute attack of ACG

Sponsors & Collaborators

• Omar Said: lead

Study Sites (1)

Athar Mohamed Mohamed Makhlouf

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Of Ophthalmology

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: April 5, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

EG (1)