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Contoura vs Wavefront Optimized Ablation

Contoura Topography-guided Ablation Versus Wavefront-optimized Ablation for Correction of Astigmatism

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05829980
Enrollment
128
Registered
2023-04-26
Start date
2023-06-30
Completion date
2025-04-30
Last updated
2023-04-26

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

Conditions

Astigmatism

Keywords

Contoura, Wavefront optimized ablation, LASIK, PRK

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.

Detailed description

In Upper Egypt, The second principal cause of blindness was uncorrected refractive errors accounting for 16% of sample population. It was reported that astigmatism (defined as cylinder power \> 0.5 D) was the most common refractive errors in children and adults followed by hyperopia and myopia. Laser vision correction has been established over the last 2 decades as a safe and effective intervention to treat refractive errors, being one of the main techniques practiced globally. However, many subjects after LASIK had uncorrected distance visual acuity (UDVA) greater than 1.0, they complain about poor night vision, glare, and double vision. As studies have shown that every 1° deviation of the astigmatic axis could result in loss of correction of 3.3%. Even residual astigmatism less than 0.50D could have an actual impact on visual quality. Excimer laser ablation used in the correction of refracted errors especially astigmatism may reduce quality of vision, and that is attributed to the induced optical aberrations. The most prevalent of these optical aberrations is the spherical aberration. Among multiple sophisticated profiles that developed to optimize visual outcomes, wavefront optimized profile which compensate for corneal curvature to reduce spherical aberration. The topographic guided profiles which consider the shape of the anterior corneal surface. Contoura topography guided ablation corrects astigmatic power and axis to create a more uniform, aberration-free cornea. Treating astigmatism can be challenging as the conventional patterns of Excimer laser treatment of astigmatism is known to be less predictable than that of spherical refractive errors.

Interventions

PROCEDURELaser assisted in-situ keratomileusis

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.

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

Sponsors

Hebatallah MT Abdelmoniem
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Postoperative UDVA compared to preoperative CDVA (in LogMAR)3 monthUCVA 3 month after surgery compared to baseline preoperative CDVA
Number of lines of preoperative CDVA compared to postoperative3 monthChange in lines of CDVA from baseline preoperative to 3 month postoperative (in LogMAR)
Amount of Residual Astigmatism postoperatively (in Diopters)3 monthresidual astigmatism 3 month postoperatively
Postoperative mean spherical equivalent MSE compared to Preoperative MSE (in Diopters)3 monthchanges in mean spherical equivalent baseline preoperative to 3 month postoperative

Secondary

MeasureTime frameDescription
Change in Contrast sensitivity test3 month
Amount of High order aberrations3 month(Spherical aberration, trefoil, vertical & horizontal coma)

Contacts

Primary ContactMohamed S. Saad Abdallah, Professor
mohsayedsaad@aun.edu.eg01001825024
Backup ContactHany O. Elsedfy, Ass. Prof.
helsedfy@aun.edu.eg01005263681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026