Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03786861
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Amin Faisal Ellakwa, 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).

Condition or disease Intervention/treatment Phase
Myopia Procedure: corneal WFG group Procedure: aberration free group Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Corneal Wavefront Guided Versus Aberration Free Transepithelial Photorefractive Keratectomy in Myopic Patients With High Pre-existing Corneal Higher Order Aberrations
Actual Study Start Date : January 12, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 42 eyes in 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)
Procedure: corneal WFG group
TransPRK 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.

Procedure: aberration free group
TransPRK 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)

Active Comparator: 24 eyes in 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)
Procedure: corneal WFG group
TransPRK 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.

Procedure: aberration free group
TransPRK 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)




Primary Outcome Measures :
  1. corneal wavefront customized treatments and aberration free aspheric treatments [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients 21 years or older with stable refraction for more than 1 year
Accepts Healthy Volunteers:   Yes
Criteria

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

Layout table for additonal information
Responsible Party: Amin Faisal Ellakwa, assistant professor, Menoufia University
ClinicalTrials.gov Identifier: NCT03786861     History of Changes
Other Study ID Numbers: Al Hekma Center
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amin Faisal Ellakwa, Menoufia University:
aberration free
corneal wavefront guided
higher order aberrations
photorefractive keratectomy.

Additional relevant MeSH terms:
Layout table for MeSH terms
Pharmaceutical Solutions