Astigmatism Clinical Trial
Official title:
Contoura Topography-guided Ablation Versus Wavefront-optimized Ablation for Correction of Astigmatism
NCT number | NCT05829980 |
Other study ID # | CONvsWFO |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2023 |
Est. completion date | April 2025 |
To evaluate the efficacy, safety and accuracy of Contoura topography-guided LASIK & PRK in comparison to Wavefront optimized LASIK & PRK in virgin eyes with astigmatism.
Status | Not yet recruiting |
Enrollment | 128 |
Est. completion date | April 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Astigmatism (up to 5.0 diopters) or less. - Central corneal thickness (CCT) of 500 microns or more - Estimated Residual stromal bed thickness (RSB) of 280 microns or more - Subject has provided written informed consent Exclusion Criteria: - Keratoconus - Abnormal topography - previous ocular trauma or eye surgery - pre-existing diseases of the vitreous, macula, or optic nerve that can affect visual outcome - patients with uveitis and anterior segment pathology - patients with corneal pathology or Severe dry eye - pregnancy or breast-feeding females - uncontrolled vascular or autoimmune disease |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hebatallah MT Abdelmoniem |
Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54. doi: 10.1097/ICO.0b013e318033dbf0. — View Citation
Canones-Zafra R, Katsanos A, Garcia-Gonzalez M, Gros-Otero J, Teus MA. Femtosecond LASIK for the correction of low and high myopic astigmatism. Int Ophthalmol. 2022 Jan;42(1):73-80. doi: 10.1007/s10792-021-02001-x. Epub 2021 Aug 9. — View Citation
Gatinel D, Malet J, Hoang-Xuan T, Azar DT. Analysis of customized corneal ablations: theoretical limitations of increasing negative asphericity. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):941-8. — View Citation
Hashemi H, Fotouhi A, Yekta A, Pakzad R, Ostadimoghaddam H, Khabazkhoob M. Global and regional estimates of prevalence of refractive errors: Systematic review and meta-analysis. J Curr Ophthalmol. 2017 Sep 27;30(1):3-22. doi: 10.1016/j.joco.2017.08.009. eCollection 2018 Mar. — View Citation
Kanellopoulos AJ. Topography-modified refraction (TMR): adjustment of treated cylinder amount and axis to the topography versus standard clinical refraction in myopic topography-guided LASIK. Clin Ophthalmol. 2016 Nov 3;10:2213-2221. doi: 10.2147/OPTH.S122345. eCollection 2016. — View Citation
Lin Y, Su HJ, Yuan MZ, Zhang Y. Vector analysis of Contoura Vision for the correction of myopia and myopic astigmatism. Int J Ophthalmol. 2022 Jun 18;15(6):983-989. doi: 10.18240/ijo.2022.06.17. eCollection 2022. — View Citation
Lukenda A, Martinovic ZK, Kalauz M. Excimer laser correction of hyperopia, hyperopic and mixed astigmatism: past, present, and future. Acta Clin Croat. 2012 Jun;51(2):299-304. — View Citation
Motwani M. The use of WaveLight(R) Contoura to create a uniform cornea: the LYRA Protocol. Part 3: the results of 50 treated eyes. Clin Ophthalmol. 2017 May 16;11:915-921. doi: 10.2147/OPTH.S133841. eCollection 2017. — View Citation
Mousa A, Courtright P, Kazanjian A, Bassett K. Prevalence of visual impairment and blindness in Upper Egypt: a gender-based perspective. Ophthalmic Epidemiol. 2014 Jun;21(3):190-6. doi: 10.3109/09286586.2014.906629. Epub 2014 Apr 18. — View Citation
Villegas EA, Alcon E, Artal P. Minimum amount of astigmatism that should be corrected. J Cataract Refract Surg. 2014 Jan;40(1):13-9. doi: 10.1016/j.jcrs.2013.09.010. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Postoperative UDVA compared to preoperative CDVA (in LogMAR) | UCVA 3 month after surgery compared to baseline preoperative CDVA | 3 month | |
Primary | Number of lines of preoperative CDVA compared to postoperative | Change in lines of CDVA from baseline preoperative to 3 month postoperative (in LogMAR) | 3 month | |
Primary | Amount of Residual Astigmatism postoperatively (in Diopters) | residual astigmatism 3 month postoperatively | 3 month | |
Primary | Postoperative mean spherical equivalent MSE compared to Preoperative MSE (in Diopters) | changes in mean spherical equivalent baseline preoperative to 3 month postoperative | 3 month | |
Secondary | Change in Contrast sensitivity test | 3 month | ||
Secondary | Amount of High order aberrations | (Spherical aberration, trefoil, vertical & horizontal coma) | 3 month |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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