Effect of Intracameral Steroids During Phacoemulsification on the Cornea

February 27, 2022 updated by: khaled gamal abueleinen, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Giza, Cairo, Egypt, 12411
        • Khaled G Abueleinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group 1
23 eyes that did not receive any intraoperative steroids
Other: Control group
23 eyes that didn't receive any intraoperative steroids
Other Names:
  • No intraoperative steroids
Active Comparator: Dexamethasone group 2
23 eyes that received intracameral dexamethasone
Drug: Dexamethasone group
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.
Other Names:
  • Intracameral Dexamethasone
Active Comparator: Triamcinolone (TA) group 3
23 eyes that received intracameral triamcinolone (TA)
Drug: Triamcinolone (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.
Other Names:
  • Intracameral triamcinolone (TA)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP
Time Frame: Three months
Intraocular pressure in mmHg rise after after phacoemulsification
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Beni-Suef University

Investigators

  • Principal Investigator: Khaled G Abueleinen, MD, PhD, Ophthalmology department, Faculty of Medicine Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2019

Primary Completion (Actual)

June 16, 2020

Study Completion (Actual)

August 15, 2020

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 27, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/30042019/Mohamed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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