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

Patients With Myopic Spherical Equivalent up to -12 Diopters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738903
• Other study ID #: CQLASIK
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Patients With Myopic Spherical Equivalent up to -12 Diopters

Intervention

Procedure:
• Femtosecond 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.

Locations

Country	Name	City	State
Egypt	TIBA eye center	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Q value	Pentacam evaluation of post-LASIK Q value	6 months
Secondary	Postoperative corneal thickness at the pupillary center	Pentacam evaluation of post-LASIK pachymetry at the pupil center	6 months