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NCT03097302 Clinical Trial

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

Corneal Astigmatism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03097302
Other study ID # 140/13
Secondary ID
Status Completed
Phase N/A
First received March 18, 2017
Last updated March 24, 2017
Start date June 6, 2013
Est. completion date July 31, 2014

Study information
Verified date March 2017
Source University Clinic Frankfurt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date July 31, 2014
Est. primary completion date July 31, 2014
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Laser keratotomy
Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Clinic Frankfurt

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change from Baseline Anterior corneal astigmatism at 3 months Anterior corneal astigmatism Before and 3 months after lens surgery
Secondary Change from Baseline Posterior corneal astigmatism at 3 months Posterior corneal astigmatism Before and 3 months after lens surgery
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