NCT06347900

Brief Summary

Corneal topographic parameters in different degrees of obstructive sleep apnea

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

March 27, 2024

Last Update Submit

April 29, 2025

Conditions

Corneal Ectasia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Control group (Group1)

Normal control subjects

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

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

Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography

Sever OSA (Group4)

Cases with mild obstructive sleep apnea (RDI) with respiratory distress index \>30

Diagnostic Test: Pentacam (corneal topographic changes detection), Polysymnography

Interventions

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.

Control group (Group1)Mild OSA (Group 2)Moderate OSA (Group 3)Sever OSA (Group4)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients above age of 20 with obstructive sleep apnea syndrome with no history of previous ocular surgeries

You may qualify if:

  • patients with diagnosed OSA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology department, Sohag University

Sohag, 82511, Egypt

Location

Study Officials

  • Elshimaa A.Mateen

    Assistant professor of ophthalmology, Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 4, 2024

Study Start

January 1, 2024

Primary Completion

April 30, 2024

Study Completion

December 30, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations

EG(1)