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Clinical Trials/NCT05271058
NCT05271058
Completed
Phase 3

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

Cairo University1 site in 1 country69 target enrollmentJune 16, 2019

Overview

Phase
Phase 3
Intervention
Control group
Conditions
Corneal Edema
Sponsor
Cairo University
Enrollment
69
Locations
1
Primary Endpoint
Central corneal thickness (CCT)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 16, 2019
End Date
August 15, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

khaled gamal abueleinen

professor

Cairo University

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
  • 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

Arms & Interventions

Control group 1

23 eyes that did not receive any intraoperative steroids

Intervention: Control group

Dexamethasone group 2

23 eyes that received intracameral dexamethasone

Intervention: Dexamethasone group

Triamcinolone (TA) group 3

23 eyes that received intracameral triamcinolone (TA)

Intervention: Triamcinolone (TA) group

Outcomes

Primary Outcomes

Central corneal thickness (CCT)

Time Frame: Three months

Central corneal thickness in microns after phacoemulsification that was compared to preoperative values

Endothelial cell loss

Time Frame: Three months

Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values

Corneal edema

Time Frame: First day postoperative

Clinical grade of corneal edema on the first postoperative day

Secondary Outcomes

  • IOP(Three months)

Study Sites (1)

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