Evaluation of Lacrimal Punctal Changes by Anterior Segment Optical Coherence Tomography AS-OCT After Topical Combined Antibiotics and Steroids Treatment in Cases of Inflammatory Punctual Stenosis

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT05028907
Collaborator
(none)
64
1
2
8
8

Study Details

Study Description

Brief Summary

Punctal stenosis is an important etiological factor that should be considered when assessing patients with epiphora. Anatomically, acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus is narrowed or occluded and also can be accompanied by canalicular ductal stenosis.1,2. Defining an anatomical clear cut-off value for punctal stenosis is difficult due to wide variations in patients' demographics. Clinically, punctal stenosis is defined as a punctum size restricting tear drainage in the absence of distal tear drainage abnormalities.2 Acquired punctal stenosis can be involutional, inflammatory, infectious or idiopathic.3,4 Inflammatory endogenous causes include chronic blepharitis, dry eye disease and ocular cicatricial pemphigoid.3 Exogenous noxious stimuli may be chemical such as topical or systemic medications, or physical as irradiation or mechanical. The harmful effect of topical medications such as antiglaucomatous drops, dexamesathone, mitomycin-C and the systemic medications such 5-Fluorouracil or paclitaxel may be related to the medication themselves, the preservatives as benzalkonium chloride in the commercial preparations, or duration of treatment with those medications.3,5-9 The basic ultra-structure response to those various noxious stimuli is early punctal occlusion by edema which is followed by conjunctival overgrowth, keratinization of punctal walls and cicatricial punctal stenosis.

Although spectral-domain OCT is still being widely used on the retina, its anterior segment module is considered a new modality for imaging of proximal lacrimal excretory passage and tears meniscus height (TMH).

Recent studies showed the ability of using AS-OCT to differentiate between various punctal causes of epiphora and improve the understanding of the lacrimal punctal structure in vivo.10-12 The aim of this work is to evaluate the role of AS-OCT in evaluation the punctal changes after treatment by antibiotics and steroids.

Condition or Disease Intervention/Treatment Phase
  • Drug: 5 mg chloramphenicol, 1 mg dexamethasone sodium phosphate, 0.25 mg tetryzoline hydrochloride, 2 mg Hydroxypropyl Methyl Cellulose, 10 mg α-tocopherol acetate and 8 mg macrogol 400).
  • Drug: sodium hyaluronate, polyethylene and propylene glycol based) three times daily for three months
Phase 4

Detailed Description

Punctal stenosis is an important etiological factor that should be considered when assessing patients with epiphora. Anatomically, acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus is narrowed or occluded and also can be accompanied by canalicular ductal stenosis.1,2. Defining an anatomical clear cut-off value for punctal stenosis is difficult due to wide variations in patients' demographics. Clinically, punctal stenosis is defined as a punctum size restricting tear drainage in the absence of distal tear drainage abnormalities.2 Acquired punctal stenosis can be involutional, inflammatory, infectious or idiopathic.3,4 Inflammatory endogenous causes include chronic blepharitis, dry eye disease and ocular cicatricial pemphigoid.3 Exogenous noxious stimuli may be chemical such as topical or systemic medications, or physical as irradiation or mechanical. The harmful effect of topical medications such as antiglaucomatous drops, dexamesathone, mitomycin-C and the systemic medications such 5-Fluorouracil or paclitaxel may be related to the medication themselves, the preservatives as benzalkonium chloride in the commercial preparations, or duration of treatment with those medications.3,5-9 The basic ultra-structure response to those various noxious stimuli is early punctal occlusion by edema which is followed by conjunctival overgrowth, keratinization of punctal walls and cicatricial punctal stenosis.

Although spectral-domain OCT is still being widely used on the retina, its anterior segment module is considered a new modality for imaging of proximal lacrimal excretory passage and tears meniscus height (TMH).

Recent studies showed the ability of using AS-OCT to differentiate between various punctal causes of epiphora and improve the understanding of the lacrimal punctal structure in vivo.10-12 The aim of this work is to evaluate the role of AS-OCT in evaluation the punctal changes after treatment by antibiotics and steroids.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Lacrimal Punctal Changes by Anterior Segment Optical Coherence Tomography AS-OCT After Topical Combined Antibiotics and Steroids Treatment in Cases of Inflammatory Punctual Stenosis
Actual Study Start Date :
Nov 15, 2020
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: group one (cases with inflamatory punctal stenosis treated with steroids and antibiotics)

patients with inflammatory punctal stenosis were treated by steroids and antibiotics and evaluated by anterior segment optical coherence tomography before and after treatment

Drug: 5 mg chloramphenicol, 1 mg dexamethasone sodium phosphate, 0.25 mg tetryzoline hydrochloride, 2 mg Hydroxypropyl Methyl Cellulose, 10 mg α-tocopherol acetate and 8 mg macrogol 400).
The patients were advised to apply the drops 5 times daily for the first week, three times daily for the next two weeks and one time daily for another one week. The patients were examined before treatment, one week, one month and three months later.

Placebo Comparator: control group

patients with inflammatory punctal stenosis received only preservative free tear substitutes

Drug: sodium hyaluronate, polyethylene and propylene glycol based) three times daily for three months
The patients were advised to apply the drops 5 times daily for the first week, three times daily for the next two weeks and one time daily for another one week. The patients were examined before treatment, one week, one month and three months later.

Outcome Measures

Primary Outcome Measures

  1. widening of the punctum [3 months]

    the widening in the punctum after treatment which could be identified by anterior sehment optical coherence tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients included aged 21 years or more who developed acquired inflammatory punctal edema and were complaining of epiphora. Epiphora of the included groups was grade2 according to Kashkoli's classification and grade 1:5 according to Munk's classification.
Exclusion Criteria:
  • Patients excluded who had history of previous ocular and lacrimal surgery, trauma, lower lid margin malposition or laxity, dry eye (for control group), glaucoma, corneal abnormalities (abrasions, keratitis), congenital punctal anomalies, nasolacrimal duct obstruction, mucocele, pyocele were excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Sohag Egypt 82524

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hany Mahmoud, clinical researcher, Sohag University
ClinicalTrials.gov Identifier:
NCT05028907
Other Study ID Numbers:
  • S20-159
First Posted:
Aug 31, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021