Effect of Intracameral Steroids During Phacoemulsification on the Cornea

Study Overview
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Brief Summary
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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.

Detailed Description
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Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count. 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.

Official Title
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Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium

Conditions
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Corneal Edema

Intervention / Treatment
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* Other: Control group
* Drug: Dexamethasone group
* Drug: Triamcinolone (TA) group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group 1<br>23 eyes that did not receive any intraoperative steroids | Other: Control group<br>* 23 eyes that didn't receive any intraoperative steroids<br>* Other names: No intraoperative steroids;|
| Active Comparator: Dexamethasone group 2<br>23 eyes that received intracameral dexamethasone | Drug: Dexamethasone group<br>* 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.<br>* Other names: Intracameral Dexamethasone;|
| Active Comparator: Triamcinolone (TA) group 3<br>23 eyes that received intracameral triamcinolone (TA) | Drug: Triamcinolone (TA) group<br>* 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.<br>* Other names: Intracameral triamcinolone (TA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal edema | Clinical grade of corneal edema on the first postoperative day | First day postoperative | 
| Central corneal thickness (CCT) | Central corneal thickness in microns after phacoemulsification that was compared to preoperative values | Three months | 
| Endothelial cell loss | Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP | Intraocular pressure in mmHg rise after after phacoemulsification | Three months |