NCT05829980

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

April 13, 2023

Last Update Submit

April 24, 2023

Conditions

Astigmatism

Keywords

ContouraWavefront optimized ablationLASIKPRK

Outcome Measures

Primary Outcomes (4)

  • Change in Postoperative UDVA compared to preoperative CDVA (in LogMAR)

    UCVA 3 month after surgery compared to baseline preoperative CDVA

    3 month

  • 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

  • Amount of Residual Astigmatism postoperatively (in Diopters)

    residual astigmatism 3 month postoperatively

    3 month

  • 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 Outcomes (2)

  • Change in Contrast sensitivity test

    3 month

  • Amount of High order aberrations

    3 month

Study Arms (4)

Group A

Contoura topography-guided LASIK

Procedure: Laser assisted in-situ keratomileusis

Group B

Contoura topography-guided PRK

Procedure: Photorefractive keratectomy

Group C

Wavefront-optimized LASIK

Procedure: Laser assisted in-situ keratomileusis

Group D

Wavefront-optimized PRK

Procedure: Photorefractive keratectomy

Interventions

Laser assisted in-situ keratomileusisPROCEDURE

Laser-Assisted In Situ Keratomileusis is a procedure that permanently changes the shape of the cornea using an excimer laser and the mechanical microkeratome (a blade device) used to cut a flap in the cornea.

Also known as: LASIK
Group AGroup C
Photorefractive keratectomyPROCEDURE

Photorefractive keratectomy is a laser refractive procedure used to ablate the corneal stroma to correct refractive errors without cutting flap

Also known as: PRK
Group BGroup D

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

participants who are candidates and scheduled for excimer laser treatment either LASIK or PRK

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 24746251BACKGROUND

  • 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.

    PMID: 29564404BACKGROUND

  • 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.

    PMID: 23115960BACKGROUND

  • 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.

    PMID: 17413947BACKGROUND

  • 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.

    PMID: 35814884BACKGROUND

  • 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.

    PMID: 24355718BACKGROUND

  • 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.

    PMID: 11923232BACKGROUND

  • 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.

    PMID: 27843292BACKGROUND

  • 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.

    PMID: 28553071BACKGROUND

  • 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.

    PMID: 34370173BACKGROUND

MeSH Terms

Conditions

Astigmatism

Interventions

Keratomileusis, Laser In SituPhotorefractive Keratectomy

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Corneal Surgery, LaserLaser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeKeratectomyRefractive Surgical ProceduresOphthalmologic Surgical Procedures

Study Officials

  • Mohamed A. Sayed, Ass. Prof.

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mohamed S. Saad Abdallah, Professor

CONTACT

01001825024mohsayedsaad@aun.edu.eg

Hany O. Elsedfy, Ass. Prof.

CONTACT

01005263681helsedfy@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 26, 2023

Study Start

June 1, 2023

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

April 26, 2023

Record last verified: 2023-04