Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

Myopia Clinical Trial

Official title:

Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452448
• Other study ID #: 030490
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 10, 2018
• Est. completion date: June 10, 2020

Study information

• Verified date: June 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Description:

The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 10, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Myopia up to -8.0 D and astigmatism up to -2.0D.

2. Cases above 18 years of age with a stable refraction for at least one year.

Exclusion Criteria:

1. Keratoconus.

2. Patients with collagen diseases.

3. Previous LASIK or any other refractive surgery.

4. Severe dry eye syndrome.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• LASIK
All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of ocular aberrations	3. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery	3 months
Primary	Visual acuity	Unaided as well as best corrected visual acuity	3 months
Primary	Manifest refraction	Manifest refraction	3 months