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Status unknownNCT03498144Updated Apr 13, 2018

Diagnosis of Acquired Punctal Stenosis Using Anterior Segment Optical Coherence Tomography

An observational study in Punctal Stenosis, sponsored by Minia University. Status unknown. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by Minia University · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
40 Years to 60 Years
Sex
All
01

Study 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).

Read the detailed description

(B)Examination:

  1. External examination: should be done to rule out causes of watering other than punctal stenosis (facial palsy, lacrimal pump failure, swelling in lacrimal sac area and regurge test)
  2. Slit lamp examination: for tear meniscus, lid margin, conjunctiva and punctual orifice
  3. Fluorescein dye disappearance test: performed with a drop of 2% fluorescein in lower conjunctival sac, patient is instructed not to wipe the eyes. After 5 minutes, presence of staining in the tear film is assessed with cobalt blue filter.
  4. Probing and lacrimal syringing, if patent confirms punctal stenosis to be the cause of epiphora rather than block in the lower lacrimal drainage system.
  5. Anterior segment optical coherence tomography examination (AS-OCT) for the lower punctum: measuring the outer puntcal diametre, inner punctal diameter and punctal depth.

Examination of the lower punctum was performed using Spectral Domain OCT machine; RTVue model-RT100 CAM system (Optovue Inc., Fremont, CA, USA) version 6.2, by attaching the cornea/anterior module lens (CAM). CAM lens has a wide-angle, high-magnification lens of 10 mm working distance. The axial resolution was 5 μm, and the lateral resolution was 8 μm. The scan beam has wavelength of 840 ± 10 nm. The two red external illumination (light emitting diode ) LED on headrest were approximated on each side of the lower punctum for proper illumination and imaging of the punctum. Gentle eversion of the medial part of the lower lid was performed to expose the lower lid punctum, so the vertical canaliculus was brought to be at an axial plain without undue stretching or pressure to the lower lid. Line scan was the used examination scan, containing 1020 A-scans/line, and is 8mm in length.

Measurements of the external punctal diameter, internal punctal diameter, and punctal depth were performed on the B-scan image of the lower punctum (by selecting it from the Review window), using distance measurement tool. External punctal diameter was measured as a line connecting highest points on the medial and lateral punctal walls. Internal punctal diameter was measured as a horizontal line just above the narrowing. The distance between the line representing the external punctal diameter and the floor of the punctum was calculated and referred to the punctal depth

Results:

Data wil be collected and statistically analysed

02

Conditions studied

  • Punctal Stenosis

Keywords

  • acquired punctal stenosis
  • epiphora
  • lower punctum
  • AS-OCT
03

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adults with acquired punctal stenosis

Inclusion criteria

Patients with acquired punctal stenosis

Exclusion criteria

Exclusion Criteria:

  1. Punctal agenesis
  2. Congenital punctal stenosis
  3. Allergic occlusion
  4. Lid malposition
  5. Canalicular, nasolacrimal, sac and duct obstruction
  6. Previous eyelid or lacrimal drainage surgery
  7. Untreated conjunctivitis, blepharitis
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceAnterior segment OCT

    lower punctum examination by AS-OCT

    Also known as: (RTVue model-RT100, with cornea/anterior module lens (CAM system )

05

What researchers measure

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

    Time frame: one month

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 22848141 ↗
  • 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. PubMed 21982102 ↗
  • 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. PubMed 22346116 ↗
  • 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. PubMed 25215411 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03498144
Lead sponsor
Minia University
Responsible party
Heba Radi AttaAllah (Lecturer of Ophthalmology/ Ophthalmology department/Faculty of Medicine/(Principal Investigator), Minia University) — Principal investigator
First posted
Apr 13, 2018
Start date
May 1, 2018 (estimated)
Primary completion
Jun 1, 2018 (estimated)
Completion
Jul 1, 2018 (estimated)
Last update
Apr 13, 2018

Study contacts

Heba AttaAllah, MD
Contact
heba.ali@mu.edu.eg
+201002554107

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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