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OpenTrials
Completed

NCT Number: NCT06434155

Social History and Glaucoma Progression

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: OCT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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