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Topical nonsteroidal anti-inflammatory drug effect on patients with pseudoexfoliation syndrome during cataract surgery

Phase 3
Recruiting
Conditions
Anterior segment inflammation and complications after cataract surgery in patients with pseudoexfoliation syndrome.
Age-related cataract
Registration Number
IRCT20160919029871N3
Lead Sponsor
Guilan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
96
Inclusion Criteria

Having Significant cataract (grade 3 and higher) and clinical signs of PEX.
The patient should not be used systemic or inhaled NSAIDs within 1 week before surgery and the patients should not use the inhaled or systemic corticosteroids within 15 days after surgery

Exclusion Criteria

Having known hypersensitivity to any components of the NSAIDs
uncontrolled chronic ocular or systemic inflammatory disease; a history of eye trauma and any retinal and macular disease, any intraocular complication during surgery (vitreous loss)
The patient who must be treated with systemic anti-inflammatory medications for extensive inflammation following cataract surgery

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of subjects with anterior chamber inflammation based on cell count (CELL) and percentage of subjects with anterior chamber inflammation based on protein content based on the rating of the San-working Group (0 to 4 degrees). Timepoint: 1, 3, 7 and 30 days after surgery. Method of measurement: Clinical examination.
Secondary Outcome Measures
NameTimeMethod
The degree of opacity of the anterior capsule (ACO) (grade 0-4) and degree of opacity of the posterior capsule (PCO) (grade 0-4). Timepoint: 1,3,6 months postoperatively. Method of measurement: photo slit examination.
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