NCT03498144

Brief Summary

Purpose of the study To evaluate the lower puntum dimensions in cases of acquired punctal stenosis(APS), using anterior segment optical coherence tomography (AS-OCT).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

April 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

April 2, 2018

Last Update Submit

April 6, 2018

Conditions

Keywords

acquired punctal stenosisepiphoralower punctumAS-OCT

Outcome Measures

Primary Outcomes (1)

  • Lower punctum dimensions in cases with acquired punctual stenosis, compared with lower punctal dimensions in normal subjects

    External punctum diameter measured in µm, internal punctum diameter, measured in µ m, punctal depth measured in µ m

    one month

Study Arms (2)

Patients with acquired punctal stenosis

Patients with acquired punctal stenosis with epiphora

Device: Anterior segment OCT

Control subjects

normal subjects, without evidence of any punctal abnormalities.

Device: Anterior segment OCT

Interventions

lower punctum examination by AS-OCT

Also known as: (RTVue model-RT100, with cornea/anterior module lens (CAM system )
Control subjectsPatients with acquired punctal stenosis

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adults with acquired punctal stenosis

You may qualify if:

  • Patients with acquired punctal stenosis

You may not qualify if:

  • Punctal agenesis
  • Congenital punctal stenosis
  • Allergic occlusion
  • Lid malposition
  • Canalicular, nasolacrimal, sac and duct obstruction
  • Previous eyelid or lacrimal drainage surgery
  • Untreated conjunctivitis, blepharitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Soiberman U, Kakizaki H, Selva D, Leibovitch I. Punctal stenosis: definition, diagnosis, and treatment. Clin Ophthalmol. 2012;6:1011-8. doi: 10.2147/OPTH.S31904. Epub 2012 Jul 3.

    PMID: 22848141BACKGROUND
  • Kakizaki H, Takahashi Y, Iwaki M, Nakano T, Asamoto K, Ikeda H, Goto E, Selva D, Leibovitch I. Punctal and canalicular anatomy: implications for canalicular occlusion in severe dry eye. Am J Ophthalmol. 2012 Feb;153(2):229-237.e1. doi: 10.1016/j.ajo.2011.07.010. Epub 2011 Oct 6.

    PMID: 21982102BACKGROUND
  • Kashkouli MB, Pakdel F, Kiavash V. Assessment and management of proximal and incomplete symptomatic obstruction of the lacrimal drainage system. Middle East Afr J Ophthalmol. 2012 Jan;19(1):60-9. doi: 10.4103/0974-9233.92117.

    PMID: 22346116BACKGROUND
  • Wawrzynski JR, Smith J, Sharma A, Saleh GM. Optical coherence tomography imaging of the proximal lacrimal system. Orbit. 2014 Dec;33(6):428-32. doi: 10.3109/01676830.2014.949793. Epub 2014 Sep 12.

    PMID: 25215411BACKGROUND

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Heba AttaAllah, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology/ Ophthalmology department/Faculty of Medicine/(Principal Investigator)

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 13, 2018

Study Start

May 1, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

April 13, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share