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

March 24, 2017 updated by: Myriam Böhm, University Clinic Frankfurt

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

23

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Total corneal refractive power at 3 months
Time Frame: Before and 3 months after lens surgery
Total corneal astigmatism (anterior and posterior astigmatism)
Before and 3 months after lens surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Anterior corneal astigmatism at 3 months
Time Frame: Before and 3 months after lens surgery
Anterior corneal astigmatism
Before and 3 months after lens surgery
Change from Baseline Posterior corneal astigmatism at 3 months
Time Frame: Before and 3 months after lens surgery
Posterior corneal astigmatism
Before and 3 months after lens surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinic Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2013

Primary Completion (Actual)

July 31, 2014

Study Completion (Actual)

July 31, 2014

Study Registration Dates

First Submitted

March 18, 2017

First Submitted That Met QC Criteria

March 24, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Via a Publication in a reviewed journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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