Effect of Intracameral Steroids During Phacoemulsification on the Cornea

Phase 3

Completed

• Conditions: Corneal Edema
• Interventions: Other: Control group; Drug: Triamcinolone (TA) group; Drug: Dexamethasone group

• Registration Number: NCT05271058
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-16
• Primary Completion: 2020-06-16
• Study Completion: 2020-08-15
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-27
• Last Update Submitted: 2022-02-27
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group 1	Control group	23 eyes that did not receive any intraoperative steroids
Triamcinolone (TA) group 3	Triamcinolone (TA) group	23 eyes that received intracameral triamcinolone (TA)
Dexamethasone group 2	Dexamethasone group	23 eyes that received intracameral dexamethasone

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
IOP	Three months	Intraocular pressure in mmHg rise after after phacoemulsification

Trial Locations

Locations (1)

Khaled G Abueleinen; 🇪🇬 Giza, Cairo, Egypt