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

NCT ID: NCT05028907

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2021-07-15

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.

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.

Conditions

Ophthalmopathy , Lacrimal System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

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).

Intervention Type: DRUG

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.

control group

patients with inflammatory punctal stenosis received only preservative free tear substitutes

Group Type: PLACEBO_COMPARATOR

sodium hyaluronate, polyethylene and propylene glycol based) three times daily for three months

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Hany Mahmoud

clinical researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University

Sohag, , Egypt

Countries

Egypt

Other Identifiers

S20-159

Identifier Type: -

Identifier Source: org_study_id