Clinical Trials Directory

Trials / Completed

CompletedNCT03786861

Corneal WFG Versus AF Trans PRK in Myopic Patients With High Corneal HOA

Corneal Wavefront Guided Versus Aberration Free Transepithelial Photorefractive Keratectomy in Myopic Patients With High Pre-existing Corneal Higher Order Aberrations

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Menoufia University · Academic / Other
Sex
All
Age
21 Years – 52 Years
Healthy volunteers
Accepted

Summary

compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

Detailed description

Objectives:to compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs). Background: Corneal WFG and aberration free treatments have been proposed as methods to achieve better visual, refractive, and optical outcomes. Methods: prospective case series was conducted in El-Hekma Eye-LASIK center, Menoufia governorate, Egypt during the period from January 2017 to December 2017. TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing either aberration free or corneal WFG patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany). Uncorrected distance visual acuity (UDVA), manifest and cycloplegic refractions, best spectacle corrected distance visual acuity (CDVA), thorough slit lamp examination and corneal topography were assessed and repeated six months postoperatively.

Conditions

Interventions

TypeNameDescription
PROCEDUREcorneal WFG groupTransPRK using ESIRIS flying spot excimer laser system (SCHWIND AMARIS®500E, SCHWIND eye-tech-solutions, Kleinhostheim, Germany), with 500 Hz repetition rate for faster treatments and scanning spots and with smart pulse technology. Eye-tracking during laser ablation was achieved using a 1050 Hz infrared eye tracker centered on the pupil. Static cyclotorsion control (SCC) compensation was obtained for all patients in corneal WFG group.
PROCEDUREaberration free groupTransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)

Timeline

Start date
2017-01-12
Primary completion
2017-12-31
Completion
2017-12-31
First posted
2018-12-26
Last updated
2018-12-26

Source: ClinicalTrials.gov record NCT03786861. Inclusion in this directory is not an endorsement.