NCT04240938

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

January 21, 2020

Last Update Submit

January 23, 2020

Conditions

Lacrimal Passage Obstruction

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Lacrimal sac mucocele

OTHER

Adult patients with lacrimal sac mucocele

Procedure: Dacryocystorhinostomy

Interventions

DacryocystorhinostomyPROCEDURE

Anastomosis between lacrimal sac and nasal cavity

Lacrimal sac mucocele

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lacrimal sac mucocele
  • Acquired type

You may not qualify if:

  • No previous lacrimal sac surgery
  • Suspected lacrimal sac malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Interventions

Dacryocystorhinostomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeOstomy

Study Officials

  • Mohamed F Ibrahiem, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Adult Dacryocystocele
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

March 1, 2017

Primary Completion

November 21, 2019

Study Completion

December 30, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)