Influence of Trabeculectomy and Phaco-trabeculectomy on C... | NCT02945202

Studies
Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism

NCT02945202

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Oct 27, 2016Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Astigmatism
Glaucoma

Interventions

Biometry
Refraction
Corneal Topography

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 2017Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Oct 20, 2016

First Submission Date that Met QC Criteria

Oct 25, 2016

First Posted Date

Oct 26, 2016Estimated

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

Oct 26, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.

Detailed Description

Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All Eyes	Other	All eyes undergo the same interventions. These are the following examinations: Biometry, Refraction and Corneal Topography. The examinations take place 6 months after surgery	Device: Biometry Device: Refraction Device: Corneal Topography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biometry	Device	All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery	All Eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in Astigmatism [Diopters (dpt)]		preoperative astigmatism compared to 6 months postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
Age ≥18 years

Exclusion Criteria:

Acute or chronic corneal diseases

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism
D005901	Glaucoma

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases
D009798	Ocular Hypertension

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001699	Biometry
D012029	Refraction, Ocular
D019781	Corneal Topography

Ancestor Terms

ID	Term
D013223	Statistics as Topic
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D015991	Epidemiologic Measurements

Browse Leaves

Not provided

Browse Branches

Not provided