Tomographic Analysis of Anterior, Posterior, Total Cornea... | NCT03097302

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

NCT03097302

Sponsor

University Clinic Frankfurt

Status

Completed

Last Update Posted

Mar 31, 2017Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Corneal Astigmatism

Interventions

Laser keratotomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2013Actual

Primary Completion Date

Jul 31, 2014Actual

Completion Date

Jul 31, 2014Actual

First Submitted Date

Mar 18, 2017

First Submission Date that Met QC Criteria

Mar 24, 2017

First Posted Date

Mar 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2017

Last Update Posted Date

Mar 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Myriam Böhm, Professor Dr. med. Thomas Kohnen, University Clinic FrankfurtPrincipal Investigator

Lead Sponsor

University Clinic FrankfurtOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser keratotomy	Procedure	Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Via a Publication in a reviewed journal.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided