Clinical trial NCT06347900: Corneal Topographic Changes in Different Grades of OSA
Official title: Corneal Topographic Changes in Different Grades of Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Ectasia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients above age of 20 with obstructive sleep apnea syndrome with no history of previous ocular surgeries

Brief summary: Corneal topographic parameters in different degrees of obstructive sleep apnea

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* patients with diagnosed OSA

Exclusion Criteria:

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

Primary outcomes:
measure: Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.
timeFrame: 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ophthalmology department, Sohag University
Study officials:
affiliation: Assistant professor of ophthalmology, Sohag University
name: Elshimaa A.Mateen
role: PRINCIPAL_INVESTIGATOR
References: