Corneal Topographic Changes in Different Grades of OSA

Corneal Ectasia Clinical Trial

Official title:

Corneal Topographic Changes in Different Grades of Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06347900
• Other study ID #: Soh-Med-23-09-7PD
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Sohag University
• Contact: Elshimaa A.Mateen
• Phone: 021282223427
• Email: elshimaa.moussa[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Corneal topographic parameters in different degrees of obstructive sleep apnea

Description:

Obstructive sleep apnea (OSA) syndrome is a disease characterized by recurrent total or partial upper airway collapse during sleep, interrupting or reducing the airflow, and after ward resulting in temporary awakening which causes restoration of flow of the upper airway. These intermittent complete (apnea) or partial (hypopnea) respiratory cessations decrease blood oxygen levels (hypoxia).

Upper airway stenosis causes hypoxemia and hypercapnia, which can lead to multiple organ dysfunction and is associated with systemic diseases, such as hypertension, diabetes, and coronary arteriosclerosis, and changes in the eyes include floppy eyelid syndrome, keratoconus, and glaucoma.

The prevalence of OSA is between 2% and 10% in females and 4-20% in males and obesity is a major risk factor for the development of OSA.

With all the adverse effects associated with OSA, its secondary effects cause several ocular complications. Previous studies have shown that OSA is associated with increased risks of several vision-threatening and nonthreatening ocular disorders, including senile cataracts, normal-tension glaucoma, retinal ischemia, conjunctival hyperemia, and dry eye.

Several contributory mechanisms to the ocular complications of OSA have been reported, including intermittent hypoxia, oxidative stress, systemic inflammatory responses (such as interleukin-6 (IL-6), IL-8, tumor necrosis factor-alpha (TNF-α), C-Reactive protein (CRP), matrix metalloproteinase 9 (MMP-9), vascular cell adhesion molecule (VCAM), intercellular adhesion molecule (ICAM), selectins), sympathetic system overaction, damage effects of endothelin-1, and disruption of the blood-retinal barrier (BRB) (6-8). There are limited publications that manipulate the corneal topographic parameters in different degrees of OSA, especially in the Egyptian population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• patients with diagnosed OSA

Exclusion Criteria:

• Any corneal scars, previous ocular surgeries, patients with keratoconus

Related Conditions & MeSH terms

• Corneal Ectasia

Intervention

Diagnostic Test:
• Pentacam (corneal topographic changes detection), Polysymnography
Pentacam for recording corneal parameters in different stages of OSA patients. Polysymnography for for detction of hyponea, oxygen saturation and desaturation and staging of OSA in different patients.

Locations

Country	Name	City	State
Egypt	Ophthalmology department, Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.	Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.	3 monthes