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

M

Menoufia University

Status

Completed

Conditions

Myopia

Treatments

Procedure: aberration free group
Procedure: corneal WFG group

Study type

Interventional

Funder types

Other

Identifiers

NCT03786861
Al Hekma Center

Details and patient eligibility

About

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).

Full 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.

Enrollment

33 patients

Sex

All

Ages

21 to 52 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

33 participants in 2 patient groups

42 eyes in aberration free group
Active Comparator group
Description:
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)
Treatment:
Procedure: aberration free group
Procedure: corneal WFG group
24 eyes in corneal WFG group
Active Comparator group
Description:
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)
Treatment:
Procedure: aberration free group
Procedure: corneal WFG group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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