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

Primary Purpose

Myopia

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
LASIK
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser in situ keratomileusis

Arm Description

A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK)

Outcomes

Primary Outcome Measures

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
Visual acuity
Unaided as well as best corrected visual acuity
Manifest refraction
Manifest refraction

Secondary Outcome Measures

Full Information

First Posted
June 26, 2020
Last Updated
June 26, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04452448
Brief Title
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
Official Title
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser in situ keratomileusis
Arm Type
Experimental
Arm Description
A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK)
Intervention Type
Device
Intervention Name(s)
LASIK
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of ocular aberrations
Description
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
Time Frame
3 months
Title
Visual acuity
Description
Unaided as well as best corrected visual acuity
Time Frame
3 months
Title
Manifest refraction
Description
Manifest refraction
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Myopia up to -8.0 D and astigmatism up to -2.0D. Cases above 18 years of age with a stable refraction for at least one year. Exclusion Criteria: Keratoconus. Patients with collagen diseases. Previous LASIK or any other refractive surgery. Severe dry eye syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab Mossallam, PhD
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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