NCT01481792

Brief Summary

Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3.7 years

First QC Date

November 23, 2011

Last Update Submit

May 10, 2016

Conditions

Myopia

Keywords

Keratorefractive Surgical Procedures

Outcome Measures

Primary Outcomes (2)

  • Effectiveness

    Achieved change in refraction (spherical equivalent, SE) in diopters will be compared with attempted change in refraction (SE) in diopters. Data will be reported as fraction of eyes within an error (achieved - attempted) of +/- 0.5 diopters (SE) and within an error of +/- 1 diopters (SE).

    Refraction one year after surgery

  • Safety

    Data will be reported as: * Percentage of eyes with best spectacle corrected visual acuity (BSCVA) worse than 20/40 for eyes with BSCVA of 20/20 or better before survey * Percentage of eyes that lose 2 Snellen lines or more of BSCVA

    One year after surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the Department of Ophthalmology, Aarhus University Hospital, for keratorefractive surgical correction of myopia

You may qualify if:

  • Indication for keratorefractive correction of myopia
  • Patient consent to undergo keratorefractive correction of myopia

You may not qualify if:

  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, consultant, MD, PhD

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 30, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

DK(1)