Social History and Glaucoma Progression

Glaucoma Open-Angle Clinical Trial

— OCT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06434155
• Other study ID #: 17200545
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1584
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Open-Angle
• Glaucoma, Open-Angle

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT structural parameters	RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT	6 months