NCT03786861

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

September 2, 2018

Last Update Submit

December 20, 2018

Conditions

Myopia

Keywords

aberration freecorneal wavefront guidedhigher order aberrationsphotorefractive keratectomy.

Outcome Measures

Primary Outcomes (1)

  • corneal wavefront customized treatments and aberration free aspheric treatments

    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

    1year

Study Arms (2)

42 eyes in aberration free group

ACTIVE COMPARATOR

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 groupProcedure: aberration free group

24 eyes in corneal WFG group

ACTIVE COMPARATOR

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 groupProcedure: aberration free group

Interventions

corneal WFG groupPROCEDURE

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.

24 eyes in corneal WFG group42 eyes in aberration free group
aberration free groupPROCEDURE

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)

24 eyes in corneal WFG group42 eyes in aberration free group

Eligibility Criteria

Age21 Years - 52 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailspatients 21 years or older with stable refraction for more than 1 year
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Myopic patients with or without astigmatism

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 2, 2018

First Posted

December 26, 2018

Study Start

January 12, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

December 26, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share