Adult Dacryocystocele Among Patients With Epiphora | NCT04240938

Studies
Adult Dacryocystocele Among Patients With Epiphora

NCT04240938

Sponsor

Minia University

Status

Completed

Last Update Posted

Jan 27, 2020Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Lacrimal Passage Obstruction

Interventions

Dacryocystorhinostomy

Countries

Egypt

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

Jan 2020

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

Mar 1, 2017Actual

Primary Completion Date

Nov 21, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Jan 21, 2020

First Submission Date that Met QC Criteria

Jan 23, 2020

First Posted Date

Jan 27, 2020Actual

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

Jan 23, 2020

Last Update Posted Date

Jan 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Patients with lacrimal dacryocystocele were chosen for the study. Dacryocystorhinostomy were done for them after their evaluation.

Detailed Description

Evaluation for lacrimal passage in the included patients using syringing, probing and dye disappearance test. Dacryocystorhinostomy were done for all patients and followed up for at least 6 months.

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lacrimal sac mucocele	Other	Adult patients with lacrimal sac mucocele	Procedure: Dacryocystorhinostomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dacryocystorhinostomy	Procedure	Anastomosis between lacrimal sac and nasal cavity	Lacrimal sac mucocele

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patency of the lacrimal passage	Disappearance of the watering of the eye reported by the patients and by fluorescein disappearance test	2 weeks
Disappearance of lacrimal sac swelling	No evident swelling in the medial side of the eye	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lacrimal sac mucocele
Acquired type

Exclusion Criteria:

No previous lacrimal sac surgery
Suspected lacrimal sac malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed F Ibrahiem, MD	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Minya	Minya Governorate	61111	Egypt

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

Intervention Browse Module

MeSH Terms

ID	Term
D003608	Dacryocystorhinostomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D010030	Ostomy

Browse Leaves

Not provided

Browse Branches

Not provided