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

Sponsor
Omar Said (Other)
Overall Status
Completed
CT.gov ID
NCT06000176
Collaborator
(none)
120
1
15.5
7.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Optical coherence tomography angiography

Detailed Description

After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).

Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.

For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.

For qualitative data Chi square test used to compare between two or more than two qualitative groups.

Bivariate Pearson correlation test to test the association between variables The probability value (P-value) < 0.05 was considered as statistical significant

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma
Actual Study Start Date :
Apr 5, 2022
Actual Primary Completion Date :
Jul 20, 2023
Actual Study Completion Date :
Jul 20, 2023

Arms and Interventions

Arm Intervention/Treatment
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
diagnostic test OCTA macula and ONH

Outcome Measures

Primary Outcome Measures

  1. OCTA macula and ONH [We will recruit patient that include the inclusion criteria from april2022 to july 2023]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Athar Mohamed Mohamed Makhlouf Fayoum Egypt

Sponsors and Collaborators

  • Omar Said

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omar Said, Assistant Professor Of Ophthalmology, Fayoum University
ClinicalTrials.gov Identifier:
NCT06000176
Other Study ID Numbers:
  • M557
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023