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Clinical Trials/NCT06434155
NCT06434155
Completed
Not Applicable

Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma

Assiut University1 site in 1 country1,584 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma Open-Angle
Sponsor
Assiut University
Enrollment
1584
Locations
1
Primary Endpoint
OCT structural parameters
Status
Completed
Last Updated
last year

Overview

Brief Summary

The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments

Detailed Description

Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH. When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
July 1, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Khaled Abdelazeem

Associate Professor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • IOP measurements more than 21 mmHg
  • Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
  • Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
  • Eyes with baseline macular and ONH OCT images and ONH photograps

Exclusion Criteria

  • Participants with significant retinal disease.
  • non-glaucomatous optic neuropathy.
  • anomalous discs
  • any retinal pathology.
  • history of cataract or glaucoma surgery will not be exclusion criteria.

Outcomes

Primary Outcomes

OCT structural parameters

Time Frame: 6 months

RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT

Study Sites (1)

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