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CompletedNCT06000176Updated Aug 21, 2023

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

An observational study in Glaucoma,Primary Open-Angle ,Primary Angle Closure, sponsored by Omar Said. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Omar Said · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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

02

Conditions studied

  • Glaucoma,Primary Open-Angle ,Primary Angle Closure

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03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's enrollment of 120 is above the median of 101 across 385 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Omar Said is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceOptical coherence tomography angiography

    diagnostic test OCTA macula and ONH

06

What researchers measure

Primary outcomes

  1. OCTA macula and ONH

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

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

07

Study locations

1 site
  • Athar Mohamed Mohamed Makhlouf
    Fayoum, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Jul 2023, 15 months.

Of 110 non-industry observational studies under Glaucoma, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 208. This study's 15 months is below that.

Counting every sponsor, half of 134 studies reached it within 31 months; a quarter within 12 and three quarters within 208.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2023
First posted
Aug 21, 2023
StartActual
Apr 5, 2022
Primary completionActual
Jul 20, 2023
CompletionActual
Jul 20, 2023
Last update
Aug 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06000176
Lead sponsor
Omar Said
Responsible party
Omar Said (Assistant Professor Of Ophthalmology, Fayoum University) — Sponsor-investigator
First posted
Aug 21, 2023
Start date
Apr 5, 2022
Primary completion
Jul 20, 2023
Completion
Jul 20, 2023
Last update
Aug 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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