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NCT05271058 Clinical Trial

Effect of Intracameral Steroids During Phacoemulsification on the Cornea

Corneal Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05271058
Other study ID # FMBSUREC/30042019/Mohamed
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 16, 2019
Est. completion date August 15, 2020

Study information
Verified date February 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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. 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Control group
23 eyes that didn't receive any intraoperative steroids
Drug:
• 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.

Locations
Country Name City State
Egypt Khaled G Abueleinen Giza Cairo

Sponsors (2)
Lead Sponsor Collaborator
Cairo University Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome
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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