NCT03097302

Brief Summary

To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

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

June 6, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 18, 2017

Last Update Submit

March 24, 2017

Conditions

Corneal Astigmatism

Keywords

laser-assisted keratotomyanterior astigmatismposterior astigmatismtotal corneal refractive powernomogram

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Total corneal refractive power at 3 months

    Total corneal astigmatism (anterior and posterior astigmatism)

    Before and 3 months after lens surgery

Secondary Outcomes (2)

  • Change from Baseline Anterior corneal astigmatism at 3 months

    Before and 3 months after lens surgery

  • Change from Baseline Posterior corneal astigmatism at 3 months

    Before and 3 months after lens surgery

Interventions

Laser keratotomyPROCEDURE

Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.

Eligibility Criteria

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

Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism during lens surgery

You may qualify if:

  • \- Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism

You may not qualify if:

  • Eyes with irregular corneal astigmatism such as keratoconus, previous corneal surgery, acute or chronic ophthalmic diseases of the anterior segment and intraoperative complications were not included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Astigmatism

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 Dr. med. Thomas Kohnen

Study Record Dates

First Submitted

March 18, 2017

First Posted

March 31, 2017

Study Start

June 6, 2013

Primary Completion

July 31, 2014

Study Completion

July 31, 2014

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Via a Publication in a reviewed journal.