Changes in Choroidal Thickness After Non Penetrating Deep... | NCT03160690

Studies
Changes in Choroidal Thickness After Non Penetrating Deep Sclerectomy

NCT03160690

Sponsor

Germans Trias i Pujol Hospital

Status

Unknown status

Last Update Posted

May 19, 2017Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Choroidal Thickness
Open Angle Glaucoma
Non Penetrating Deep Sclerectomy

Interventions

Non penetrating deep sclerectomy

Countries

Spain

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

May 2017

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

Jun 17, 2017Estimated

Primary Completion Date

Nov 17, 2017Estimated

Completion Date

May 17, 2018Estimated

First Submitted Date

May 17, 2017

First Submission Date that Met QC Criteria

May 18, 2017

First Posted Date

May 19, 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

May 18, 2017

Last Update Posted Date

May 19, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sandra Gómez Sánchez, Principal Investigator, Germans Trias i Pujol HospitalPrincipal Investigator

Lead Sponsor

Germans Trias i Pujol HospitalOTHER

Collaborators

Name	Class
Pau Romera Romero	UNKNOWN
Jorge Loscos Arenas	UNKNOWN
Nevena Romanic Bubalo	UNKNOWN
Jordi Castellví Manent

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

Prospective and observational study to determine if choroidal thickness increases after non penetrating deep sclerectomy in patients with open angle glaucoma

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non penetrating deep sclerectomy	Procedure	Non penetrating deep sclerectomy for open angle glaucoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Choroidal thickness	Choroidal thickness measured by optic coherence tomography	before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy
Change in Intraocular pressure	mmHg	before and 1 week, 1 month, 3 months and 6 months after non penetrating deep sclerectomy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Progressive Primary Open Angle Glaucoma

Exclusion Criteria:

Age under 18yrs
Myopia or Hyperopia higher than -6D or +6D
Secondary glaucoma
Ocular surgery other than cataract
Other ocular pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with progressive open angle glaucoma although topical treatment with indication for non penetrating deep sclerectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandra Gómez Sánchez, MD	Contact	0034934978919		gomezsanchez.s@gmail.com

Overall Officials

Name	Affiliation	Role
Sandra Gómez Sánchez, MD	Germans Trias i Pujol Hospital	Principal Investigator
Pau Romera Romero, MD	Germans Trias i Pujol Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Germans Trias i Pujol Hospital		Badalona	Barcelona	08916	Spain

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
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided