Effect of Intracameral Steroids During Phacoemulsification on the Cornea
NCT ID: NCT05271058
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
69 participants
INTERVENTIONAL
2019-06-16
2020-08-15
Brief Summary
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Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.
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Detailed Description
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Methods: 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.
On the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.
One month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.
mean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Methods: 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.
PREVENTION
NONE
Study Groups
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Control group 1
23 eyes that did not receive any intraoperative steroids
Control group
23 eyes that didn't receive any intraoperative steroids
Dexamethasone group 2
23 eyes that received intracameral dexamethasone
Dexamethasone group
23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification.
Triamcinolone (TA) group 3
23 eyes that received intracameral triamcinolone (TA)
Triamcinolone (TA) group
23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification.
Interventions
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Control group
23 eyes that didn't receive any intraoperative steroids
Dexamethasone group
23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification.
Triamcinolone (TA) group
23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* uneventful phacoemulsification operation
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
Cairo University
OTHER
Responsible Party
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khaled gamal abueleinen
professor
Principal Investigators
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Khaled G Abueleinen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmology department, Faculty of Medicine Cairo University
Locations
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Khaled G Abueleinen
Giza, Cairo Governorate, Egypt
Countries
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Other Identifiers
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FMBSUREC/30042019/Mohamed
Identifier Type: -
Identifier Source: org_study_id
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