Corneal EctasiaNCT06347900
Corneal Topographic Changes in Different Grades of OSA
An observational study of Corneal Ectasia, run by Sohag University at 1 site in Egypt.
Trial summary
Corneal topographic parameters in different degrees of obstructive sleep apnea Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Ectasia
- What is being tested?
- Pentacam (corneal topographic changes detection), Polysymnography
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients above age of 20 with obstructive sleep apnea syndrome with no history of previous ocular surgeries
Who may be able to join
- patients with diagnosed OSA
Who cannot join
- Any corneal scars, previous ocular surgeries, patients with keratoconus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Topographic Changes in Different Grades of Obstructive Sleep Apnea Syndrome
Corneal topographic parameters in different degrees of obstructive sleep apnea
Read the 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.
- Conditions
- Corneal Ectasia
- Being tested
- Pentacam (corneal topographic changes detection), Polysymnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam (corneal topographic changes detection), PolysymnographyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Group1) | Normal control subjects Receives: Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography | |
| Mild OSA (Group 2) | Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 5-15 Receives: Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography | |
| Moderate OSA (Group 3) | Cases with mild obstructive sleep apnea (RDI) with respiratory distress index 15-30 Receives: Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography | |
| Sever OSA (Group4) | Cases with mild obstructive sleep apnea (RDI) with respiratory distress index >30 Receives: Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
- Investigators
- Elshimaa A.Mateen, Principal investigator, Assistant professor of ophthalmology, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347900
- Sponsor's protocol ID
- Soh-Med-23-09-7PD
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2024
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Topographic Changes in Different Grades of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT06347900
- Acronym / sponsor ID
- Soh-Med-23-09-7PD
- Conditions
- Corneal Ectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group (Group1) | – | Diagnostic Test: Pentacam (corneal topographic changes detection), PolysymnographyNormal control subjects |
| Mild OSA (Group 2) | – | Diagnostic Test: Pentacam (corneal topographic changes detection), PolysymnographyCases with mild obstructive sleep apnea (RDI) with respiratory distress index 5-15 |
| Moderate OSA (Group 3) | – | Diagnostic Test: Pentacam (corneal topographic changes detection), PolysymnographyCases with mild obstructive sleep apnea (RDI) with respiratory distress index 15-30 |
| Sever OSA (Group4) | – | Diagnostic Test: Pentacam (corneal topographic changes detection), PolysymnographyCases with mild obstructive sleep apnea (RDI) with respiratory distress index >30 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients above age of 20 with obstructive sleep apnea syndrome with no history of previous ocular surgeries
Key inclusion criteria (1 listed)
- patients with diagnosed OSA
Key exclusion criteria (1 listed)
- Any corneal scars, previous ocular surgeries, patients with keratoconus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentacam (corneal topographic changes detection), PolysymnographyPentacam 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. | Diagnostic test | Control group (Group1), Mild OSA (Group 2), Moderate OSA (Group 3), Sever OSA (Group4) |
Primary outcome
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.
Time frame: 3 monthes
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
Keratoconus, Corneal Ectasia
RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elshimaa A.Mateen principal investigator
Assistant professor of ophthalmology, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ectasia, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratometric readings in diopters, corneal thickness in um, average progression index value, anterior and posterior corneal elevation values. (time frame: 3 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.