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Tomographic Analysis of Anterior, Posterior, Total Corneal Refractive Power Changes After Laser-assisted Keratotomy

Sponsor
University Clinic Frankfurt (Other)
Overall Status
Completed
CT.gov ID
NCT03097302
Collaborator
(none)
23
Enrollment
13.8
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laser keratotomy

Detailed Description

This study investigated patients' eyes with low to moderate total corneal refractive power determined with Scheimpflug tomography (Pentacam HR) after penetrating femtosecond laser-assisted keratotomy (pFLAK) and laser lens surgery. The anterior corneal astigmatism, posterior corneal astigmatism and total corneal refractive power were determined before, 1 month and 3 months after lens surgery. Vector analysis according to the Alpins' method was used to calculate surgically induced astigmatism (SIA).

Study Design

Study Type:
Observational
Actual Enrollment :
23 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tomographic Analysis of Anterior, Posterior and Total Corneal Refractive Power Changes After Femtosecond Laser-assisted Keratotomy After Laser Lens Surgery
Actual Study Start Date :
Jun 6, 2013
Actual Primary Completion Date :
Jul 31, 2014
Actual Study Completion Date :
Jul 31, 2014

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Total corneal refractive power at 3 months [Before and 3 months after lens surgery]

    Total corneal astigmatism (anterior and posterior astigmatism)

Secondary Outcome Measures

  1. Change from Baseline Anterior corneal astigmatism at 3 months [Before and 3 months after lens surgery]

    Anterior corneal astigmatism

  2. Change from Baseline Posterior corneal astigmatism at 3 months [Before and 3 months after lens surgery]

    Posterior corneal astigmatism

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism
Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Clinic Frankfurt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Myriam Böhm, Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt
ClinicalTrials.gov Identifier:
NCT03097302
Other Study ID Numbers:
  • 140/13
First Posted:
Mar 31, 2017
Last Update Posted:
Mar 31, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Myriam Böhm, Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt
laser-assisted keratotomy
anterior astigmatism
posterior astigmatism
total corneal refractive power
nomogram
Additional relevant MeSH terms:
Astigmatism

Study Results

No Results Posted as of Mar 31, 2017