Corneal Edema Clinical Trial
Official title:
Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
Verified date | February 2022 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids. Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.
Status | Completed |
Enrollment | 69 |
Est. completion date | August 15, 2020 |
Est. primary completion date | June 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - Cataract grades 2 to 5 nuclear cataract (LOCS III scale) - uneventful phacoemulsification operation Exclusion Criteria: - extremely hard cataract grade 6 nuclear cataract (LOCS III scale) - soft cataract - subluxated lenses or zonular dehiscence - associated ocular pathology such as glaucoma - any signs of uveitis - trauma - retinal detachment - vitrectomized or silicone filled eyes - corneal disease such as Fuch's dystrophy, corneal opacity - previous refractive corneal surgery - Cases that developed ruptured posterior capsule and vitreous loss - those lost to follow up were excluded and randomly replaced by the next chronological patient |
Country | Name | City | State |
---|---|---|---|
Egypt | Khaled G Abueleinen | Giza | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Beni-Suef University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Corneal edema | Clinical grade of corneal edema on the first postoperative day | First day postoperative | |
Primary | Central corneal thickness (CCT) | Central corneal thickness in microns after phacoemulsification that was compared to preoperative values | Three months | |
Primary | Endothelial cell loss | Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values | Three months | |
Secondary | IOP | Intraocular pressure in mmHg rise after after phacoemulsification | Three months |
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