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

Q Value Customized Versus Wavefront Optimized Ablation in Femtosecond Laser-Assisted LASIK for Myopia and Myopic Astigmatism. A Contralateral Comparative Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04738903
Enrollment
40
Registered
2021-02-04
Start date
2020-06-01
Completion date
2021-06-30
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Myopic Spherical Equivalent up to -12 Diopters

Keywords

Femtosecond LASIK, Q value, Wave-front Optimized (WFO)

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.

Interventions

PROCEDUREFemtosecond laser assisted LASIK eye surgery

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Q value6 monthsPentacam evaluation of post-LASIK Q value

Secondary

MeasureTime frameDescription
Postoperative corneal thickness at the pupillary center6 monthsPentacam evaluation of post-LASIK pachymetry at the pupil center

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026