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

Assiut University

Status: Completed

Conditions: Patients With Myopic Spherical Equivalent up to -12 Diopters

Treatments: Procedure: Femtosecond laser assisted LASIK eye surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04738903

CQLASIK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Custom Q treatment group

Active Comparator group

Description:

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

Treatment:

Procedure: Femtosecond laser assisted LASIK eye surgery

Wave-front optimized (WFO) group

Active Comparator group

Description:

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

Treatment:

Procedure: Femtosecond laser assisted LASIK eye surgery