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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | patients receive only medical treatment in the form of topical 0.05% cyclosporin (Restasis®, Allergan Inc) twice daily for 6 months. |
|
| group B | Active Comparator | patients receive mini-Monoka stent insertion in the lower canaliculus for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.05% cyclosporin (Restasis®, Allergan Inc) | Drug | study the efficacy of topical 0.05% cyclosporin eye drops (Restasis®, Allergan Inc) in management of grade 1 and 2 acquired punctal stenosis (group A) |
| Measure | Description | Time Frame |
|---|---|---|
| functional success | change in munk score | 6 months |
| anatomical success | grading of the punctum by measuring its size in millimeters on slit lamp | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Nassief | Farwaniya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farwanyia Hospital | Al Farwaniyah | Farwanyia | 13001 | Kuwait |
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| mini-monoka stent | Device | insertion of mini-monoka stent in the lower punctum in management of grade 1 and 2 acqquired punctal stenosis (group B) |
|
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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