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Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK

Primary Purpose

Patients With Myopic Spherical Equivalent up to -12 Diopters

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Femtosecond laser assisted LASIK eye surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Myopic Spherical Equivalent up to -12 Diopters focused on measuring Femtosecond LASIK, Q value, Wave-front Optimized (WFO)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Candidates for Laser vision correction (LVC) with

  1. Myopic Spherical Equivalent up to -12 diopters.
  2. Myopic astigmatism up to -6 diopters.
  3. Corneal thinnest location ≥ 500 um 4- Residual stromal bed ≥ 300 um.

Exclusion Criteria:

  1. Patients not candidates for LVC.
  2. Hyperopic patients or mixed astigmatism.
  3. Systemic disease that contraindicates LVC.
  4. Intra- or post-operative complications. 5- Previous corneal surgery

Sites / Locations

  • TIBA eye center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Custom Q treatment group

Wave-front optimized (WFO) group

Arm Description

For every patient, the eye with the greater myopic spherical equivalent (SE) will be assigned for the Custom-Q treatment group.

For every patient, the other eye with the lesser myopic SE will be assigned for the WFO treatment group

Outcomes

Primary Outcome Measures

Postoperative Q value
Pentacam evaluation of post-LASIK Q value

Secondary Outcome Measures

Postoperative corneal thickness at the pupillary center
Pentacam evaluation of post-LASIK pachymetry at the pupil center

Full Information

First Posted
February 1, 2021
Last Updated
July 19, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04738903
Brief Title
Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK
Official Title
Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK for Myopia and Myopic Astigmatism. A Contralateral Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
Corneal asphericity is expressed numerically as the "Q-value". A minus value means that corneal curvature flattens towards the periphery and the cornea is prolate in shape, but when the curvature steepens towards the periphery, the cornea is oblate in shape and has a positive Q-value. The current study evaluates the effect of LASIK eye surgery on corneal asphericity by comparing 2 software treatment platforms; the Q value customized ablation versus the conventional Wave-front optimized ablation in a fellow eye study pattern.
Detailed Description
The standard excimer laser correction of myopia is associated with decreased visual quality in the form of a decrease in contrast sensitivity and night vision. This degradation of the visual quality is attributed to changes in the corneal asphericity that increase the high order aberrations (HOAs), such as spherical aberrations because it leads to shifting of the corneal asphericity towards the oblate shape. The wavefront-optimized (WFO) profile avoids the creation of new HOAs, but it is not able to treat those which are already present pre-operatively. The Q-adjusted treatments correct the sphero-cylindrical refractive errors and try to maintain the corneal asphericity at the same time, but like the WFO ablation profiles, it is limited to correcting the spherical aberrations and not the non-rotational symmetric HOAs. Some studies compared Lasers of two different platforms on contralateral eyes of the same patient in order to minimize inter-patient differences such as corneal wound healing and corneal biomechanics. By exclusion of these inter-patient differences, a more accurate judgment on the outcomes can be achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Myopic Spherical Equivalent up to -12 Diopters
Keywords
Femtosecond LASIK, Q value, Wave-front Optimized (WFO)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Custom Q treatment group
Arm Type
Active Comparator
Arm Description
For every patient, the eye with the greater myopic spherical equivalent (SE) will be assigned for the Custom-Q treatment group.
Arm Title
Wave-front optimized (WFO) group
Arm Type
Active Comparator
Arm Description
For every patient, the other eye with the lesser myopic SE will be assigned for the WFO treatment group
Intervention Type
Procedure
Intervention Name(s)
Femtosecond laser assisted LASIK eye surgery
Intervention Description
FS-LASIK eye surgery includes corneal flap creation with femtosecond laser using the Femtosecond laser WaveLight FS200 followed by excimer laser vision correction of the patient's refractive error using excimer laser WaveLight EX500.
Primary Outcome Measure Information:
Title
Postoperative Q value
Description
Pentacam evaluation of post-LASIK Q value
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Postoperative corneal thickness at the pupillary center
Description
Pentacam evaluation of post-LASIK pachymetry at the pupil center
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Candidates for Laser vision correction (LVC) with Myopic Spherical Equivalent up to -12 diopters. Myopic astigmatism up to -6 diopters. Corneal thinnest location ≥ 500 um 4- Residual stromal bed ≥ 300 um. Exclusion Criteria: Patients not candidates for LVC. Hyperopic patients or mixed astigmatism. Systemic disease that contraindicates LVC. Intra- or post-operative complications. 5- Previous corneal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Abdel-Radi, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
TIBA eye center
City
Assiut
ZIP/Postal Code
71516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28187180
Citation
Piao J, Li YJ, Whang WJ, Choi M, Kang MJ, Lee JH, Yoon G, Joo CK. Comparative evaluation of visual outcomes and corneal asphericity after laser-assisted in situ keratomileusis with the six-dimension Amaris excimer laser system. PLoS One. 2017 Feb 10;12(2):e0171851. doi: 10.1371/journal.pone.0171851. eCollection 2017.
Results Reference
background
PubMed Identifier
36320050
Citation
Mostafa MM, Abdelmotaal H, Abdelazeem K, Goda I, Abdel-Radi M. Q-value customized versus wavefront-optimized ablation in femtosecond laser-assisted LASIK for myopia and myopic astigmatism: a prospective contralateral comparative study. Eye Vis (Lond). 2022 Nov 2;9(1):43. doi: 10.1186/s40662-022-00312-3.
Results Reference
derived

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Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK

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