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Effect of Intracameral Steroids During Phacoemulsification on the Cornea

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05271058
Enrollment
69
Registered
2022-03-08
Start date
2019-06-16
Completion date
2020-08-15
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Edema

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.

Interventions

OTHERControl group

23 eyes that didn't receive any intraoperative steroids

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.

DRUGTriamcinolone (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.

Sponsors

Beni-Suef University
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial cell lossThree monthsCorneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values
Corneal edemaFirst day postoperativeClinical grade of corneal edema on the first postoperative day
Central corneal thickness (CCT)Three monthsCentral corneal thickness in microns after phacoemulsification that was compared to preoperative values

Secondary

MeasureTime frameDescription
IOPThree monthsIntraocular pressure in mmHg rise after after phacoemulsification

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026