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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Procedure: corneal WFG group; Procedure: aberration free group

• Registration Number: NCT03786861
• Lead Sponsor: Menoufia University

Brief 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.

Study Timeline

• Study Start: 2017-01-12
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Study First Submitted: 2018-09-02
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Myopic patients with or without astigmatism

Exclusion Criteria

• severe dry eye,
• blepharitis,
• corneal disease,
• contact lens warpage,
• cataract,
• uveitis
• posterior segment anomalies involving the macula or optic nerve
• systemic conditions; diabetes mellitus, connective tissue disease, pregnancy or nursing. Also, any patient who had previous ocular surgery including keratorefractive surgery was excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 eyes in corneal WFG group	aberration free group	TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing corneal WFG patterns in corneal WFG group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
42 eyes in aberration free group	aberration free group	TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free in aberration free group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
24 eyes in corneal WFG group	corneal WFG group	TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing corneal WFG patterns in corneal WFG group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
42 eyes in aberration free group	corneal WFG group	TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free in aberration free group provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)

Primary Outcome Measures

Name	Time	Method
corneal wavefront customized treatments and aberration free aspheric treatments	1year	procedure was labeled successful if achieved the desired outcomes in terms of efficacy and safety. Efficacy index was defined as the ratio between the postoperative UDVA to the preoperative CDVA while safety index was defined as the ratio between the postoperative CDVA and the preoperative CDVA. Efficacy index around 1 and safety index more than 1 were desired. Failure was considered when the above outcomes failed to be achieved along with persistence or development of any of the following complications at 6 month postoperative follow up; corneal haze, persistent epithelial defects, ectasia, sterile infiltrate, infectious keratitis, central toxic keratopathy and steroid induced complications