NCT04738903|Completed
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Sponsor study identifier
interventional
40
1 country
1
Study Start
June 1, 2020
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2020
Actual (reported)February 1, 2021
Actual (reported)February 4, 2021
Actual (reported)June 30, 2021
Actual (reported)June 30, 2021
Actual (reported)Postoperative Q value
Pentacam evaluation of post-LASIK Q value
6 months
Postoperative corneal thickness at the pupillary center
6 months
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
TIBA eye center
Asyut, 71516, Egypt
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.
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.
Mahmoud Abdel-Radi, MD
Assiut University
40 participants (actual enrollment reported by the registry).
First Submitted
February 1, 2021
First Posted
February 4, 2021
Study Start
June 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2021
Actual (reported)Study Completion
June 30, 2021
Actual (reported)Last Updated
July 20, 2021
Record last verified: 2021-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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