Contribution of SA and Coma to The Total Ocular HOA Before and After FS-LASIK Using An Aspheric Ablation Profile

July 14, 2021 updated by: Paula Sameh Youssef, Kasr El Aini Hospital

Contribution of Spherical Aberration and Coma to The Total Ocular High Order Aberration Before and After Femtosecond Laser-Assisted in Situ Keratomileusis Using An Aspheric Ablation Profile

Laser-assisted in situ keratomileusis (LASIK) is the most frequently performed refractive surgery procedure for the correction of myopia, hyperopia, and astigmatism.

There is a continuous upgrade and development in LVC surgeries correlated with the evolution of new machines and enhancement of the ablation profiles. One of the main undesirable effects of corneal refractive surgeries using conventional ablation profiles is the increase in HOAs which is associated with haloes, glare, ghost images, starburst patterns and monocular diplopia, especially in low lighting conditions and during night driving.

Over the years many ablation profiles have been developed such as wavefront-guided, wavefront optimized, topography guided, Q- Value based and aspheric ablation profiles. These profiles aim to abolish LOAs and to prevent induction or increase of pre-existing HOAs aiming to improve the quality of vision experienced post-operative.

In spite of the vast body of research in this area, there remains a gap in the literature investigating higher-order aberrations' components in-depth. Therefore, this study aims to investigate the contribution of spherical aberration and coma to the total higher order aberration before and after femtosecond assisted laser in situ keratomileusis using an aspheric ablation profile.

This current study is a Descriptive analytical study that was conducted on 34 eyes of 17 patients who underwent corneal refractive surgery.

The results were analyzed to compare the effect of FS-LASIK surgery on corneal coma and SA, and the contribution of each of them on total ocular HOAs preoperative and post-operative.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr AL Ainy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: between 18 years and 45 years
  2. Myopes from -1.50 D to -8.00 D
  3. Astigmatism less than -4.00 D
  4. Normal Corneal Tomography with a Belin Ambrosio big D value of less than 1.6

Exclusion Criteria:

  1. Unstable refraction for 1 year
  2. Corneal thickness less than 500 microns
  3. Expected Post Lasik Residual Stromal bed less than 300 microns
  4. All patients with post operative complications as epithelial overgrowth or decentered ablation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Percentage of Coma and SA to Total ocular HOA
Procedure: LASIK refractive surgery
laser vision correction for myopic eyes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of contribution of coma and spherical aberration from total ocular HOA before and after FS-LASIK.
Time Frame: 6 months

Measuring unit for coma and spherical aberrations and total ocular HOA is equivalent Diopters.

The contribution of coma and spherical aberrations to total ocular HOA will be measured as a percentage.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 10, 2021

Primary Completion (Anticipated)

October 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 14, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PSYoussef

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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