Effect of Intracameral Steroids During Phacoemulsification on the Cornea

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Corneal Edema

Treatments: Other: Control group; Drug: Dexamethasone group; Drug: Triamcinolone (TA) group

Study type: Interventional

Funder types: Other

Identifiers

NCT05271058

FMBSUREC/30042019/Mohamed

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

Control group 1

Sham Comparator group

Description:

23 eyes that did not receive any intraoperative steroids

Treatment:

Other: Control group

Dexamethasone group 2

Active Comparator group

Description:

23 eyes that received intracameral dexamethasone

Treatment:

Drug: Dexamethasone group

Triamcinolone (TA) group 3

Active Comparator group

Description:

23 eyes that received intracameral triamcinolone (TA)

Treatment:

Drug: Triamcinolone (TA) group