Corneal Topographic Changes in Different Grades of OSA

Completed

• Conditions: Corneal Ectasia
• Interventions: Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography

• Registration Number: NCT06347900
• Lead Sponsor: Sohag University

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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with diagnosed OSA

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate OSA (Group 3)	Pentacam (corneal topographic changes detection), Polysymnography	Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 15-30
Control group (Group1)	Pentacam (corneal topographic changes detection), Polysymnography	Normal control subjects
Mild OSA (Group 2)	Pentacam (corneal topographic changes detection), Polysymnography	Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 5-15
Sever OSA (Group4)	Pentacam (corneal topographic changes detection), Polysymnography	Cases with mild obstructive sleep apnea (RDI) with respiratory distress index \>30

Primary Outcome Measures

Name	Time	Method
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.	3 monthes	Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.

Trial Locations

Locations (1)

Ophthalmology department, Sohag University; 🇪🇬 Sohag, Egypt