Analysis of Topographic Corneal Parameters

Analysis of Topographic Corneal Parameters in a Large Cohort of Corneal Refractive Surgery Candidates

The Pentacam HR system (OCULUS) has been suggested to be one of the most sensitive instruments for corneal examination before corneal refractive surgery

Study Overview

• Status: Completed
• Conditions: Cornea
• Intervention / Treatment: Device: Oculus pentacam HR

Detailed Description

Retrospective non randomized study Analysis of different corneal paremeters obtained by Pentacam for corneal refractive surgery candidates during last 3 years from both sexes between 18 and 45 years K1 - K2 - K max - Pachymetry apex - Pachymetry thinnest - Distance between apex and thinnest - Back elevation - Topography shape - Keratoconus (If present)

• Study Type: Observational
• Enrollment (Actual): 2694

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients examined in Roaa LASIK center from both sexes between 18-45 years seeking corneal refractive surgery

Description

Inclusion Criteria:

• Persons from both sexes between 18 and 45 years seeking corneal refractive surgery

Exclusion Criteria:

• Previous intraocular surgery
• Previous corneal surgery
• Corneal opacity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
candidates seeking corneal refractive surgery; Persons from both sexes between 18 and 45 years seeking corneal refractive surgery	Device: Oculus pentacam HR; Examination of corneal parameters by pentacam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
corneal curvature	radii of curvature in diopters	7 months
corneal pachymetry	measured in microns	7 months

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Ahmed Abdelghany, professor, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 592/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: not plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No