NCT02503956

Brief Summary

Assessing efficacy of punctal dilatation with insertion of perforated punctal plugs for the management of acquired punctal stenosis due to allergic conjunctivitis in otherwise healthy patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

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

First Submitted

Initial submission to the registry

June 24, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2016

Completed
Last Updated

October 2, 2017

Status Verified

February 1, 2017

Enrollment Period

12 months

First QC Date

June 24, 2015

Last Update Submit

September 28, 2017

Conditions

EpiphoraConjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Epiphoric state

    Patient follow up after punctal plug removal, this is a dichotomic measure of yes/no question - weather of not the patient still suffers from tearing after treatment

    3 Months

Study Arms (2)

Treated group

EXPERIMENTAL

Patients treated with perforated punctal plugs

Device: Perforated Punctal plugs

Comparison group

ACTIVE COMPARATOR

Comparison group treated with standard of care - Lacrimal intubation with Crawford lacrimal tube

Procedure: Crawford tube insertionDevice: Crawford lacrimal tube

Interventions

Perforated Punctal plugsDEVICE

Perforated punctal plugs

Treated group
Crawford tube insertionPROCEDURE
Comparison group
Crawford lacrimal tubeDEVICE
Comparison group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from acquired punctual stenosis due to chronic allergic conjunctivitis.
  • Years old

You may not qualify if:

  • Previous manipulation of lacrimal ducts of punctum
  • Patients unable to follow study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 5590000, Israel

Location

Related Publications (6)

  • Ali MJ, Mishra DK, Baig F, Lakshman M, Naik MN. Punctal stenosis: histopathology, immunology, and electron microscopic features-a step toward unraveling the mysterious etiopathogenesis. Ophthalmic Plast Reconstr Surg. 2015 Mar-Apr;31(2):98-102. doi: 10.1097/IOP.0000000000000204.

    PMID: 24892278RESULT

  • 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: 22848141RESULT

  • Konuk O, Urgancioglu B, Unal M. Long-term success rate of perforated punctal plugs in the management of acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2008 Sep-Oct;24(5):399-402. doi: 10.1097/IOP.0b013e318185a9ca.

    PMID: 18806663RESULT

  • Mathew RG, Olver JM. Mini-monoka made easy: a simple technique for mini-monoka insertion in acquired punctal stenosis. Ophthalmic Plast Reconstr Surg. 2011 Jul-Aug;27(4):293-4. doi: 10.1097/IOP.0b013e31820ccfaf.

    PMID: 21386741RESULT

  • Hussain RN, Kanani H, McMullan T. Use of mini-monoka stents for punctal/canalicular stenosis. Br J Ophthalmol. 2012 May;96(5):671-3. doi: 10.1136/bjophthalmol-2011-300670. Epub 2012 Jan 12.

    PMID: 22241928RESULT

  • Chang M, Ahn SE, Baek S. The effect of perforated punctal plugs in the management of acquired punctal stenosis. J Craniofac Surg. 2013 Sep;24(5):1628-30. doi: 10.1097/SCS.0b013e318292c68b.

    PMID: 24036740RESULT

MeSH Terms

Conditions

Lacrimal Apparatus DiseasesConjunctivitis

Condition Hierarchy (Ancestors)

Eye DiseasesConjunctival Diseases

Study Officials

  • Itay Gabbay, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 21, 2015

Study Start

August 1, 2015

Primary Completion

July 22, 2016

Study Completion

July 22, 2016

Last Updated

October 2, 2017

Record last verified: 2017-02

Locations

IL(1)