Surgical Correction of Astigmatism | NCT01680354

Studies
Surgical Correction of Astigmatism

NCT01680354

Sponsor

Aarhus University Hospital

Status

Withdrawn

Last Update Posted

May 2, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Astigmatism

Interventions

ReLEx
LASIK

Countries

Denmark

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Institution changed surgical method to small incision lenticule extraction. Study never started.

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2012Estimated

Completion Date

Not provided

First Submitted Date

Sep 4, 2012

First Submission Date that Met QC Criteria

Sep 6, 2012

First Posted Date

Sep 7, 2012Estimated

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

Apr 30, 2014

Last Update Posted Date

May 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.

During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.

In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ReLEx	Active Comparator	One eye is treated with ReLEx the other with LASIK	Procedure: ReLEx
LASIK	Active Comparator	One eye is treated with ReLEx the other with LASIK	Procedure: LASIK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ReLEx	Procedure		ReLEx	Device: Carl Zeiss Meditec Visumax Femtosecond Laser

Measure	Description	Time Frame
Visual acuity		1 year

Measure	Description	Time Frame
Refraction		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopic astigmatism between -2.0 and -5.0 diopters
Maximal difference in spherical equivalent refraction of 2 D between eyes
No ocular or systemic disease
Not pregnant or breastfeeding
Minimum BSCVA of 0.8 (decimal)
Normal corneal topography
Sufficient corneal thickness to allow the treatment

Exclusion Criteria:

Subjects not fulfilling the above criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Aarhus University Hospital		Aarhus		DK-8000	Denmark

ID	Term
D001251	Astigmatism

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D020731	Keratomileusis, Laser In Situ

Ancestor Terms

ID	Term
D048988	Corneal Surgery, Laser
D053685	Laser Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided