Clinical trial NCT05271058: Effect of Intracameral Steroids During Phacoemulsification on the Cornea
Official title: Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Corneal Edema
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2022-03-08
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Corneal edema
timeFrame: First day postoperative
measure: Central corneal thickness (CCT)
timeFrame: Three months
measure: Endothelial cell loss
timeFrame: Three months
Secondary outcomes:
measure: IOP
timeFrame: Three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Khaled G Abueleinen
state: Cairo
Study officials:
affiliation: Ophthalmology department, Faculty of Medicine Cairo University
name: Khaled G Abueleinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: