Overview

Topical Cyclosporin A 0.05% Eye Drops for Management of Symptomatic Acquired Punctal Stenosis. A Prospective, Controlled Clinical Study.

Status:
Completed
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
A prospective, controlled, interventional clinical study, includes all patients (16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis. All patients undergo punctal dilatation, canalicular probing and nasolacrimal duct irrigation. Afterwards, patients are divided into two groups: Group A: patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months. Group B: patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months. Outcome measures are changes in Munk scoring, grading of the punctum, functional and anatomical success. Functional success is defined as Munk score 0 to 1. Anatomical success is defined as grade 3 punctum.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Farwaniya Hospital
Treatments:
Cyclosporine
Cyclosporins
Criteria
Inclusion Criteria:

- The study includes all patients (more than 16 years) with symptomatic epiphora and
diagnosed with grade 1 or grade 2 acquired punctal stenosis

Exclusion Criteria:

- Patients presented with congenital epiphora, previous eyelid surgeries, neoplastic or
traumatic causes of punctual or canalicular obstruction, or any other causes of
lacrimal passage obstruction such as canalicular, common canalicular or nasolacrimal
duct obstruction NLDO are excluded from this study.